Ferrisat

Ferrisat may be available in the countries listed below.

Ingredient matches for Ferrisat

Iron Dextran

Iron Dextran is reported as an ingredient of Ferrisat in the following countries:

• France

International Drug Name Search

Omacid

Omacid may be available in the countries listed below.

Ingredient matches for Omacid

Aluminium Hydroxide

Aluminium Hydroxide is reported as an ingredient of Omacid in the following countries:

• Oman

Magnesium Hydroxide

Magnesium Hydroxide is reported as an ingredient of Omacid in the following countries:

• Oman

International Drug Name Search

Imodium lingual

Imodium lingual may be available in the countries listed below.

Ingredient matches for Imodium lingual

Loperamide

Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Imodium lingual in the following countries:

• Switzerland

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Farthrough

Farthrough may be available in the countries listed below.

Ingredient matches for Farthrough

Sodium Picosulfate

Sodium Picosulfate monohydrate (a derivative of Sodium Picosulfate) is reported as an ingredient of Farthrough in the following countries:

• Japan

International Drug Name Search

Morphine ER

Generic Name: morphine sulfate

Dosage Form: tablet, film coated, extended release

WARNING:

Morphine sulfate extended-release tablets contain morphine sulfate, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.

Morphine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing morphine sulfate extended release tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.

Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic.

Morphine sulfate extended-release 100 mg and 200 mg tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids.

MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

Morphine ER Description

Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula:

Morphine sulfate extended-release tablets, for oral administration, are opiate analgesics supplied in 15 mg, 30 mg, 60 mg, 100 mg and 200 mg tablet strengths. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP).

Morphine sulfate extended-release tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

The 15 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.

The 30 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake.

The 60 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake.

The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, red iron oxide and yellow iron oxide.

The 200 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.

Morphine ER - Clinical Pharmacology

Morphine is a pure opioid agonist whose principal therapeutic action is analgesia. Other members of the class known as opioid agonists include substances such as oxycodone, hydromorphone, fentanyl, codeine and hydrocodone. Pharmacological effects of opioid agonists include anxiolysis, euphoria, feelings of relaxation, respiratory depression, constipation, miosis, cough suppression and analgesia. Like all pure opioid agonist analgesics, with increasing doses there is increasing analgesia, unlike with mixed agonist/ antagonists or non-opioid analgesics, where there is a limit to the analgesic effect with increasing doses. With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious which may include somnolence and respiratory depression.

Central Nervous System

The principal actions of therapeutic value of morphine are analgesia and sedation (i.e., sleepiness and anxiolysis).

The precise mechanism of the analgesic action is unknown. However, specific CNS opiate receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are likely to play a role in the expression of analgesic effects.

Morphine produces respiratory depression by direct action on brainstem respiratory centers. The mechanism of respiratory depression involves a reduction in the responsiveness of the brainstem respiratory centers to increases in carbon dioxide tension and to electrical stimulation.

Morphine depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia. Morphine causes miosis, even in total darkness. Pinpoint pupils are a sign of narcotic overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen with worsening hypoxia.

Gastrointestinal Tract and Other Smooth Muscle

Morphine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and in the duodenum. Digestion of food is delayed in the small intestine and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid induced-effects may include a reduction in gastric, biliary and pancreatic secretions, spasm of the sphincter of Oddi and transient elevations in serum amylase.

Cardiovascular System

Morphine produces peripheral vasodilation which may result in orthostatic hypotension. Release of histamine can occur and may contribute to opioid-induced hypotension. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes and sweating.

Endocrine System

Opioids have been shown to have a variety of effects on the secretion of hormones. Opioids inhibit the secretion of ACTH, cortisol and luteinizing hormone (LH) in humans. They also stimulate prolactin, growth hormone (GH) secretion and pancreatic secretion of insulin and glucagons in humans and other species, rats and dogs. Thyroid stimulating hormone (TSH) has been shown to be both inhibited and stimulated by opioids.

Immune System

Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown.

Pharmacodynamics

As with all opioids, the minimum effective plasma concentration for analgesia varies widely among patients, especially among patients who have been previously treated with potent agonist opioids. As a result, patients must be treated with individualized titration of dosage to the desired effect. The minimum effective analgesic concentration of morphine for any individual patient may increase over time due to an increase in pain, the development of new pain syndrome and/or the development of analgesic tolerance.

Plasma Level-Analgesia Relationships

In any particular patient, both analgesic effects and plasma morphine concentrations are related to the morphine dose. In non-tolerant individuals, plasma morphine concentration-efficacy relationships have been demonstrated and suggest that opiate receptors occupy effector compartments, leading to a lag-time or hysteresis, between rapid changes in plasma morphine concentrations and the effects of such changes. The most direct and predictable concentration-effect relationships can, therefore, be expected at distribution equilibrium and/or steady-state conditions.

While plasma morphine-efficacy relationships can be demonstrated in non-tolerant individuals, they are influenced by a wide variety of factors and are not generally useful as a guide to the clinical use of morphine. The effective dose in opioid-tolerant patients may be significantly greater than the appropriate dose for opioid-naive individuals. Dosages of morphine should be chosen and must be titrated on the basis of clinical evaluation of the patient and the balance between therapeutic and adverse effects.

For any fixed dose and dosing interval, morphine will have at steady-state, a lower Cmax and a higher Cmin than conventional morphine.

Concentration - Adverse Experience Relationships

Morphine sulfate extended-release tablets are associated with typical opioid-related adverse experiences. There is a general relationship between increasing morphine plasma concentration and increasing frequency of dose related opioid adverse experiences such as nausea, vomiting, CNS effects and respiratory depression. In opioid-tolerant patients, the situation is altered by the development of tolerance to opioid-related side effects and the relationship is not clinically relevant.

As with all opioids, the dose must be individualized (see DOSAGE AND ADMINISTRATION), because the effective analgesic dose for some patients will be too high to be tolerated by other patients.

Pharmacokinetics and Metabolism

Morphine sulfate is an extended-release tablet containing morphine sulfate. Morphine is released from morphine sulfate extended-release tablets somewhat more slowly than from immediate-release oral preparations. Following oral administration of a given dose of morphine, the amount ultimately absorbed is essentially the same whether the source is morphine sulfate extended-release tablets or an immediate-release formulation. Because of pre-systemic elimination (i.e., metabolism in the gut wall and liver) only about 40% of the administered dose reaches the central compartment.

Variation in the physical/mechanical properties of a formulation of an oral morphine drug product can affect both its absolute bioavailability and its absorption rate constant (ka). The formulation employed in morphine sulfate extended-release has not been shown to affect morphine's oral bioavailability, but does decrease its apparent ka. Other basic pharmacokinetic parameters (e.g., volume of distribution [Vd], elimination rate constant [ke], clearance [Cl]), are unchanged as they are fundamental properties of morphine in the organism. However, in chronic use, the possibility that shifts in metabolite to parent drug ratios may occur cannot be excluded.

When immediate-release oral morphine or morphine sulfate extended-release is given on a fixed dosing regimen, steady-state is achieved in about a day.

For a given dose and dosing interval, the AUC and average blood concentration of morphine at steady-state (Css) will be independent of the specific type of oral formulation administered so long as the formulations have the same absolute bioavailability. The absorption rate of a formulation will, however, affect the maximum (Cmax) and minimum (Cmin) blood levels and the times of their occurrence.

Absorption

Following the administration of immediate-release oral morphine products, approximately fifty percent of the morphine that will reach the central compartment intact reaches it within 30 minutes. Following the administration of an equal amount of morphine sulfate extended-release to normal volunteers, however, this extent of absorption occurs, on average, after 1.5 hours.

Food Effects

The possible effect of food upon the systemic bioavailability of morphine sulfate extended-release has not been systematically evaluated for all strengths. One study, conducted with the 30 mg morphine sulfate extended-release tablets, showed no significant differences in Cmax and AUC(0-24h) values, whether the tablet was taken while fasting or with a high fat breakfast.

Distribution

The volume of distribution (Vd) for morphine is approximately 4 liters per kilogram. Once absorbed, morphine is distributed to skeletal muscle, kidneys, liver, intestinal tract, lungs, spleen and brain. Morphine also crosses the placental membranes and has been found in breast milk.

Metabolism

Although a small fraction (less than 5%) of morphine is demethylated, for all practical purposes, virtually all morphine is converted to the 3- and 6- (M3G and M6G) glucuronide metabolites. M3G is present in the highest plasma concentration following oral administration and possesses no significant analgesic activity. M6G, while possessing analgesic activity, is present in the plasma in low concentrations.

Excretion

The elimination of morphine occurs primarily as renal excretion of morphine-3- glucuronide and its terminal elimination half-life after intravenous administration is normally 2 to 4 hours. In some studies involving longer periods of plasma sampling, a longer terminal half-life of about 15 hours was reported. A small amount of the glucuronide conjugate is excreted in the bile and there is some minor enterohepatic recycling. As with any drug, caution should be taken to guard against unanticipated accumulation if renal and/or hepatic function is seriously impaired.

Special Populations

Renal Impairment

Morphine pharmacokinetics are altered in patients with renal failure. Clearance is decreased and the metabolites, M3G and M6G, may accumulate to much higher plasma levels in these patients as compared to patients with normal renal function. 

Drug-Drug Interactions

Known drug-drug interactions involving morphine are pharmacodynamic not pharmacokinetic.

Indications and Usage for Morphine ER

Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Morphine sulfate extended-release tablets are NOT intended for use as a prn analgesic.

The morphine sulfate extended-release 100 mg and 200 mg tablet strengths are high dose, extended-release, oral morphine formulations indicated for the relief of pain in opioid-tolerant patients only.

Morphine sulfate extended-release tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.

Morphine sulfate extended-release tablets are not indicated for pain in the postoperative period if the pain is mild or not expected to persist for an extended period of time.

Morphine sulfate extended-release tablets are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

Contraindications

Morphine sulfate extended-release tablets are contraindicated in patients with known hypersensitivity to morphine or in any situation where opioids are contraindicated. This includes patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings) and in patients with acute or severe bronchial asthma or hypercarbia.

Morphine sulfate extended-release tablets are contraindicated in any patient who has or is suspected of having a paralytic ileus.

Warnings

(See also: CLINICAL PHARMACOLOGY)

MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

Morphine sulfate extended-release 100 mg and 200 mg tablets ARE FOR OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids.

Morphine sulfate extended-release 100 mg and 200 mg tablets are for use only in opioid-tolerant patients requiring daily morphine equivalent dosages of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet. Care should be taken in the prescribing of these tablet strengths. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

Misuse, Abuse and Diversion of Opioids

Morphine is an opioid agonist and a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Morphine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing morphine in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.

Morphine sulfate extended-release can be abused by crushing, chewing, snorting or injecting the dissolved product. These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose and death (see WARNINGS: Drug Abuse and Addiction).

Concerns about abuse, addiction and diversion should not prevent the proper management of pain.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Interactions with Alcohol and Drugs of Abuse

Morphine may be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause central nervous system depression because respiratory depression, hypotension and profound sedation or coma may result. (See WARNINGS: Interactions with other CNS Depressants.)

Drug Abuse and Addiction

Morphine sulfate extended-release is a mu-agonist opioid with an abuse liability similar to other opioid agonists and is a Schedule II controlled substance. Morphine and other opioids used in analgesia, can be abused and are subject to criminal diversion.

Drug addiction is characterized by compulsive use, use for non-medical purposes and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

“Drug seeking” behavior is very common in addicts and drug abusers. Drug seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Morphine sulfate extended-release, like other opioids, has been diverted for non-medical use. Careful recordkeeping of prescribing information, including quantity, frequency and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Morphine sulfate extended-release is intended for oral use only as an intact tablet. Abuse of the crushed tablet poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. Due to the presence of talc as one of the excipients in tablets, parenteral abuse can be expected to result in local tissue necrosis, infection, pulmonary granulomas and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Respiratory Depression

Respiratory depression is the chief hazard of all morphine preparations. Respiratory depression occurs most frequently in the elderly and debilitated patients as well as in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation.

Morphine should be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia or preexisting respiratory depression. In such patients, even usual therapeutic doses of morphine may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of morphine with carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or preexisting increase in intracranial pressure. Morphine produces effects which may obscure neurologic signs of further increases in pressure in patients with head injuries.

Hypotensive Effect

Morphine, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain his blood pressure has already been compromised by a depleted blood volume or a concurrent administration of drugs such as phenothiazines or general anesthetics. Morphine sulfate extended-release may produce orthostatic hypotension in ambulatory patients.

Morphine, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Interactions with other CNS Depressants

Morphine, like all opioid analgesics, should be used with great caution and in reduced dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers and alcohol because respiratory depression, hypotension and profound sedation or coma may result.

Other

Although extremely rare, cases of anaphylaxis have been reported.

Precautions

(See also: CLINICAL PHARMACOLOGY)

Special Precautions Regarding Morphine Sulfate Extended-release 100 mg and 200 mg Tablets

Morphine sulfate extended-release 100 mg and 200 mg tablets are for use only in opioid-tolerant patients requiring daily morphine equivalent dosages of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet. Care should be taken in its prescription and patients should be instructed against use by individuals other than the patient for whom it was prescribed, as this may have severe medical consequences for that individual.

General

Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Morphine sulfate extended-release does not release morphine continuously over the course of a dosing interval. The administration of single doses of morphine sulfate extended-release on a q12h dosing schedule will result in higher peak and lower trough plasma levels than those that occur when an identical daily dose of morphine is administered using conventional oral formulations on a q4h regimen. The clinical significance of greater fluctuations in morphine plasma level has not been systematically evaluated. (See DOSAGE AND ADMINISTRATION.)

Selection of patients for treatment with morphine sulfate extended-release should be governed by the same principles that apply to the use of morphine or other potent opioid analgesics. Specifically, the increased risks associated with its use in the following populations should be considered: the elderly or debilitated and those with severe impairment of hepatic, pulmonary or renal function; myxedema or hypothyroidism; adrenocortical insufficiency (e.g., Addison's Disease); CNS depression or coma; toxic psychosis; prostatic hypertrophy or urethral stricture; acute alcoholism; delirium tremens; kyphoscoliosis or inability to swallow.

The administration of morphine, like all opioid analgesics, may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Morphine may aggravate convulsions in patients with convulsive disorders and all opioids may induce or aggravate seizures in some clinical settings.

Interactions with Mixed Agonist/Antagonist Opioid Analgesics

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine and butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as morphine sulfate. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of morphine sulfate and/or may precipitate withdrawal symptoms in these patients.

Use in Pancreatic/Biliary Tract Disease

Morphine should be used with caution in patients about to undergo surgery of the biliary tract since it may cause spasm of the sphincter of Oddi. Similarly, morphine should be used with caution in patients with acute pancreatitis secondary to biliary tract disease.

Tolerance

Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.

Physical Dependence

Physical dependence is a state of adaptation that is manifested by an opioid specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate or heart rate.

In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION: Cessation of Therapy).

Information for Patients/Caregivers

If clinically advisable, patients receiving morphine sulfate extended-release or their caregivers should be given the following information by the physician, nurse or pharmacist:

1. Patients should be advised that morphine sulfate extended-release tablets contain morphine and should be taken only as directed.


2. Patients should be advised that morphine sulfate extended-release tablets were designed to work properly only if swallowed whole. Morphine sulfate extended-release tablets will release all of their morphine if split, divided, broken, chewed, dissolved or crushed resulting in the risk of a fatal overdose.


3. Patients should be advised not to change the dose of morphine without consulting their physician.


4. Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.


5. Morphine may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients started on morphine sulfate extended-release or whose dose has been changed should refrain from dangerous activity until it is established that they are not adversely affected.


6. Morphine sulfate extended-release should not be taken with alcohol or other CNS depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician because dangerous additive effects may occur resulting in serious injury or death.


7. Women of childbearing potential who become or are planning to become pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.


8. Patients should be advised that if they have been receiving treatment with morphine sulfate extended-release for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the morphine sulfate extended-release dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.


9. Morphine sulfate extended-release 100 mg and 200 mg tablets are for use only in opioid-tolerant patients requiring daily morphine equivalent dosages of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet. Special care must be taken to avoid accidental ingestion or the use by individuals (including children) other than the patient for whom it was originally prescribed, as such unsupervised use may have severe, even fatal, consequences.


10. Patients should be advised that morphine sulfate extended-release is a potential drug of abuse. They should protect it from theft and it should never be given to anyone other than the individual for whom it was prescribed.


11. Patients should be advised that they may pass empty matrix "ghosts" (tablets) via colostomy or in the stool and that this is of no concern since the active medication has already been absorbed.


12. Patients should be instructed to keep morphine sulfate extended-release in a secure place out of the reach of children. When morphine sulfate extended-release is no longer needed, the unused tablets should be destroyed by flushing down the toilet.

Use in Drug and Alcohol Addiction

Morphine sulfate extended-release is an opioid with no approved use in the management of addiction disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia.

Drug Interactions

(See also: WARNINGS)

Use with CNS Depressants

The concomitant use of other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers and alcohol may produce additive depressant effects. Respiratory depression, hypotension and profound sedation or coma may occur. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Opioid analgesics, including morphine sulfate extended-release, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Carcinogenicity/Mutagenicity/Impairment of Fertility

Studies of morphine sulfate in animals to evaluate the drug's carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy

Teratogenic Effects. CATEGORY C

Adequate animal studies on reproduction have not been performed to determine whether morphine affects fertility in males or females. There are no well controlled studies in women, but marketing experience does not include any evidence of adverse effects on the fetus following routine (short-term) clinical use of morphine sulfate products. Although there is no clearly defined risk, such experience cannot exclude the possibility of infrequent or subtle damage to the human fetus.

Morphine sulfate extended-release should be used in pregnant women only if the need for strong opioid analgesia clearly outweighs the potential risk to the fetus. (See also: PRECAUTIONS: Labor and Delivery and WARNINGS: Drug Abuse and Addiction.)

Labor and Delivery

Morphine sulfate extended-release is not recommended for use in women during and immediately prior to labor. Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation which tends to shorten labor.

Neonates whose mothers received opioid analgesics during labor should be observed closely for signs of respiratory depression. A specific narcotic antagonist, naloxone, should be available for reversal of narcotic-induced respiratory depression in the neonate.

Neonatal Withdrawal Syndrome

Chronic maternal use of opioids during pregnancy can affect the fetus with subsequent withdrawal symptoms. Neonatal withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, abnormal crying, tremor, vomiting, diarrhea and subsequent weight loss or failure to gain weight and may result in death. The onset, duration and severity of neonatal withdrawal syndrome varies based on the drug used, duration of use, the dose of last maternal use and rate of elimination by the newborn. Use standard care as medically appropriate.

Nursing Mothers

Low levels of morphine have been detected in the breast milk. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of morphine sulfate is stopped. Ordinarily, nursing should not be undertaken while a patient is receiving morphine since morphine sulfate extended-release may be excreted in the milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Morphine sulfate extended-release tablets are not to be chewed, crushed, dissolved or divided for administration.

Geriatric Use

Clinical studies of morphine sulfate extended-release did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

The adverse reactions caused by morphine are essentially those observed with other opioid analgesics. They include the following major hazards: respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.

Most Frequently Observed

Constipation, lightheadedness, dizziness, sedation, nausea, vomiting, sweating, dysphoria and euphoria.

Some of these effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down.

Less Frequently Observed Reactions

Central Nervous System: Weakness, headache, agitation, tremor, uncoordinated muscle movements, seizure, alterations of mood (nervousness, apprehension, depression, floating feelings), dreams, muscle rigidity, transient hallucinations and disorientation, visual disturbances, insomnia, increased intracranial pressure

Gastrointestinal: Dry mouth, biliary tract spasm, laryngospasm, anorexia, diarrhea, cramps, taste alteration, constipation, ileus, intestinal obstruction, dyspepsia, increases in hepatic enzymes

Cardiovascular: Flushing of the face, chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension

Genitourinary: Urine retention or hesitance, amenorrhea, reduced libido and/or potency

Dermatologic: Pruritus, urticaria, other skin rashes, edema, diaphoresis

Other: Antidiuretic effect, paresthesia, bronchospasm, muscle tremor, blurred vision, nystagmus, diplopia, miosis, anaphylaxis, malaise, thinking disturbances, vertigo

Overdosage

Acute overdosage with morphine can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, rhabdomyolysis progressing to renal failure, and, sometimes, bradycardia, hypotension and death.

The nature of the controlled-release morphine should also be taken into account when treating the overdose. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects. Deaths due to overdose may occur with abuse and misuse of morphine sulfate extended-release tablets.

In the treatment of morphine overdosage, primary attention should be given to the reestablishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen, vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

The pure opioid antagonists, such as naloxone, are specific antidotes against respiratory depression which results from opioid overdose. Naloxone should be administered intravenously; however, because its duration of action is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably reestablished. If the response to naloxone is suboptimal or not sustained, additional naloxone may be administered, as needed, or given by continuous infusion to maintain alertness and respiratory function; however, there is no information available about the cumulative dose of naloxone that may be safely administered.

Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to morphine overdose. Such agents should be administered cautiously to persons who are known or suspected to be physically dependent on morphine. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome.

Note: In an individual physically dependent on opioids, administration of the usual dose of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Use of an opioid antagonist in such a person should be avoided. If necessary to treat serious respiratory depression in the physically dependent patient, the antagonist should be administered with care and by titration with smaller than usual doses of the antagonist.

Morphine ER Dosage and Administration

(See also: CLINICAL PHARMACOLOGY, WARNINGS AND PRECAUTIONS SECTIONS)

MORPHINE SULFATE EXTENDED-RELEASE IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO OTHER OPIOID AGONISTS. MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA CAN BE ABUSED AND ARE SUBJECT TO CRIMINAL DIVERSION.

MORPHINE SULFATE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED OR CRUSHED. TAKING BROKEN, CHEWED, DISSOLVED OR CRUSHED MORPHINE SULFATE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

Physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as those outlined by the World Health Organization, the Federation of State Medical Boards Model Guidelines or the American Pain Society. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

Morphine sulfate extended-release tablets are a controlled-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows it to be administered on a more convenient schedule than conventional immediate-release oral morphine products. (See CLINICAL PHARMACOLOGY: Pharmacokinetics and Metabolism) However, morphine sulfate extended-release does not release morphine continuously over the course of a dosing interval. The administration of single doses of morphine sulfate extended-release on a q12h dosing schedule will result in higher peak and lower trough plasma levels than those that occur when an identical daily dose of morphine is administered using conventional oral formulations on a q4h regimen. The clinical significance of greater fluctuations in morphine plasma level has not been systematically evaluated.

As with any potent opioid drug product, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment experience. Although it is clearly impossible to enumerate every consideration that is important to the selection of initial dose and dosing interval of morphine sulfate extended-release, attention should be given to 1) the daily dose, potency and precise characteristics of the opioid the patient has been taking previously (e.g., whether it is a pure agonist or mixed agonist/antagonist), 2) the reliability of the relative potency estimate used to calculate the dose of morphine needed [N.B. potency estimates may vary with the route of administration], 3) the degree of opioid tolerance, if any and 4) the general condition and medical status of the patient.

The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions in the management of the pain of an individual patient.

During periods of changing analgesic requirements including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

Conversion from Immediate-release Oral Morphine to Morphine Sulfate Extended-release

A patient's daily morphine requirement is established using immediate-release oral morphine (dosing every 4 to 6 hours). The patient is then converted to morphine sulfate extended-release in either of two ways: 1) by administering one-half of the patient's 24 hour requirement as morphine sulfate extended-release on an every 12 hour schedule; or, 2) by administering one-third of the patient's daily requirement as morphine sulfate extended-release on an every 8 hour schedule. With either method, dose and dosing interval is then adjusted as needed (see discussion below). The 15 mg tablet should be used for initial conversion for patients whose total daily requirement is expected to be less than 60 mg. The 30 mg tablet strength is recommended for patients with a daily morphine requirement of 60 mg to 120 mg. When the total daily dose is expected to be greater than 120 mg, the appropriate combination of tablet strengths should be employed.

Conversion from Parentera

Fasigyn

In the US, Fasigyn is a member of the drug class amebicides and is used to treat Amebiasis, Bacterial Vaginitis, Giardiasis and Trichomoniasis.

UK matches:

• Fasigyn (SPC)

Ingredient matches for Fasigyn

Tinidazole

Tinidazole is reported as an ingredient of Fasigyn in the following countries:

• Argentina


• Australia


• Bahrain


• Belgium


• Belize


• Chile


• Colombia


• Costa Rica


• Cyprus


• Dominican Republic


• Ecuador


• Egypt


• El Salvador


• Ethiopia


• Georgia


• Greece


• Guatemala


• Guyana


• Honduras


• Hong Kong


• India


• Israel


• Jordan


• Kenya


• Kuwait


• Lebanon


• Luxembourg


• Malawi


• Mexico


• Nicaragua


• Nigeria


• Oman


• Panama


• Peru


• Portugal


• Romania


• Saudi Arabia


• Singapore


• South Africa


• Sri Lanka


• Sudan


• Sweden


• Thailand


• Uganda


• United Arab Emirates


• United Kingdom


• Venezuela

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Finasteride Alvia

Finasteride Alvia may be available in the countries listed below.

Ingredient matches for Finasteride Alvia

Finasteride

Finasteride is reported as an ingredient of Finasteride Alvia in the following countries:

• Greece

International Drug Name Search

Occlusal-HP Topical

Generic Name: salicylic acid (Topical route)

sal-i-SIL-ik AS-id

Commonly used brand name(s)

In the U.S.

• Akurza


• Aliclen


• Avosil


• Betasal


• Compound W


• Corn Removing


• Dermarest Psoriasis


• DHS Sal


• Drytex


• Duofilm


• Duoplant


• Durasal


• Freezone


• Fung-O


• Gets-It Corn/Callus Remover


• Gordofilm


• Hydrisalic


• Ionil


• Ionil Plus


• Keralyt


• Keralyt Scalp


• Lupicare


• Mediplast


• Mg217 Sal-Acid


• Mosco Corn & Callus Remover


• Neutrogena


• Occlusal-HP


• Off-Ezy


• Oxy Balance


• P & S


• Palmer's Skin Success Acne Cleanser


• Propa pH


• Salac


• Sal-Acid Plaster


• Salactic Film


• Salex


• Salitop


• Salkera


• Sal-Plant Gel


• Salvax


• Seba-Clear


• Stri-Dex


• Thera-Sal


• Therasoft Anti-Acne


• Tinamed


• Ti-Seb


• Virasal


• Wart-Off Maximum Strength


• Zapzyt

In Canada

• Acnex


• Acnomel Acne Mask


• Clear Away Wart Removal System


• Compound W One-Step Wart Remover


• Compound W Plus


• Dr. Scholl's Clear Away One Step Plantar Wart Remover


• Dr. Scholl's Cushlin Ultra Slim Callus Removers


• Dr. Scholl's Cushlin Ultra Slim Corn Removers


• Duoforte 27


• Freezone - One Step Callus Remover Pad


• Freezone - One Step Corn Remover Pad

Available Dosage Forms:

• Soap


• Lotion


• Liquid


• Foam


• Ointment


• Gel/Jelly


• Solution


• Cream


• Pad


• Paste


• Shampoo


• Dressing


• Stick

Therapeutic Class: Antiacne

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Non-Aspirin

Uses For Occlusal-HP

Salicylic acid is used to treat many skin disorders, such as acne, dandruff, psoriasis, seborrheic dermatitis of the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the dosage form and strength of the preparation.

Some of these preparations are available only with your doctor's prescription.

Before Using Occlusal-HP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Salicylic acid should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Argatroban


• Bivalirudin


• Cilostazol


• Citalopram


• Clovoxamine


• Dabigatran Etexilate


• Dipyridamole


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Heparin


• Lepirudin


• Nefazodone


• Paroxetine


• Protein C


• Rivaroxaban


• Sertraline


• Sibutramine


• Ticlopidine


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Anisindione


• Ardeparin


• Azilsartan Medoxomil


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bumetanide


• Buthiazide


• Candesartan Cilexetil


• Certoparin


• Chlorothiazide


• Chlorthalidone


• Clopamide


• Cyclopenthiazide


• Dalteparin


• Danaparoid


• Dicumarol


• Enoxaparin


• Eprosartan


• Ethacrynic Acid


• Furosemide


• Hydrochlorothiazide


• Hydroflumethiazide


• Indapamide


• Irbesartan


• Losartan


• Methyclothiazide


• Metolazone


• Nadroparin


• Olmesartan Medoxomil


• Parnaparin


• Phenindione


• Phenprocoumon


• Piretanide


• Polythiazide


• Probenecid


• Reviparin


• Tamarind


• Tasosartan


• Telmisartan


• Tinzaparin


• Torsemide


• Trichlormethiazide


• Valsartan


• Warfarin


• Xipamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease

• Diabetes mellitus (sugar diabetes)—Use of this medicine may cause severe redness or ulceration, especially on the hands or feet

• Inflammation, irritation, or infection of the skin—Use of this medicine may cause severe irritation if applied to inflamed, irritated, or infected area of the skin

• Influenza (flu) or


• Varicella (chicken pox)—This medicine should not be used in children and teenagers with the flu or chicken pox. There is a risk of Reye's syndrome.

• Kidney disease or


• Liver disease—Using this medicine for a long time over large areas could result in unwanted effects

Proper Use of salicylic acid

This section provides information on the proper use of a number of products that contain salicylic acid. It may not be specific to Occlusal-HP. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of absorption through the skin and the chance of salicylic acid poisoning.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since an occlusive dressing will increase the amount of medicine absorbed through your skin and the possibility of salicylic acid poisoning, use it only as directed. If you have any questions about this, check with your doctor.

Keep this medicine away from the eyes and other mucous membranes, such as the mouth and inside of the nose. If you should accidentally get some in your eyes or on other mucous membranes, immediately flush them with water for 15 minutes.

To use the cream, lotion, or ointment form of salicylic acid:

• Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of salicylic acid:

• Before using salicylic acid gel, apply wet packs to the affected areas for at least 5 minutes. If you have any questions about this, check with your health care professional.


• Apply enough gel to cover the affected areas, and rub in gently.

To use the pad form of salicylic acid:

• Wipe the pad over the affected areas.


• Do not rinse off medicine after treatment.

To use the plaster form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Cut the plaster to fit the wart, corn, or callus and apply.


• For corns and calluses:
  
  • Repeat every 48 hours as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
  
  
  • Corns or calluses may be soaked in warm water for 5 minutes to help in their removal.
  
  


• For warts:
  
  • Depending on the product, either:
    
    • Apply plaster and repeat every 48 hours as needed, or
      
      • Apply plaster at bedtime, leave in place for at least 8 hours, remove plaster in the morning, and repeat every 24 hours as needed.
      
      
    
    
  
  
  • Repeat for up to 12 weeks as needed, or as directed by your doctor, until wart is removed.
  
  


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

To use the shampoo form of salicylic acid:

• Before applying this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine to work up a lather and rub well into the scalp for 2 or 3 minutes, then rinse. Apply the medicine again and rinse thoroughly.

To use the soap form of salicylic acid:

• Work up a lather with the soap, using hot water, and scrub the entire affected area with a washcloth or facial sponge or mitt.


• If you are to use this soap in a foot bath, work up rich suds in hot water and soak the feet for 10 to 15 minutes. Then pat dry without rinsing.

To use the topical solution form of salicylic acid for acne:

• Wet a cotton ball or pad with the topical solution and wipe the affected areas.


• Do not rinse off medicine after treatment.

To use the topical solution form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• This medicine is flammable. Do not use it near heat or open flame or while smoking.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Avoid breathing in the vapors from the medicine.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Apply the medicine one drop at a time to completely cover each wart, corn, or callus. Let dry.


• For warts—Repeat one or two times a day as needed for up to 12 weeks, or as directed by your doctor, until wart is removed.


• For corns and calluses—Repeat one or two times a day as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.


• Corns and calluses may be soaked in warm water for 5 minutes to help in their removal.


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

Unless your hands are being treated, wash them immediately after applying this medicine to remove any medicine that may be on them.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For cream dosage form:
  
  • For corns and calluses:
    
    • Adults and children—Use the 2 to 10% cream as needed. Use the 25 to 60% cream one time every three to five days.
    
    
  
  


• For gel dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 5% gel one time a day.
    
    
  
  
  • For psoriasis:
    
    • Adults and children—Use the 5% gel one time a day.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 5 to 26% gel one time a day.
    
    
  
  


• For lotion dosage form:
  
  • For acne:
    
    • Adults and children—Use the 1 to 2% lotion one to three times a day.
    
    
  
  
  • For dandruff and antiseborrhic dermatitis of the scalp:
    
    • Adults and children—Use the 1.8 to 2% lotion on the scalp one or two times a day.
    
    
  
  


• For ointment dosage form:
  
  • For acne:
    
    • Adults and children—Use the 3 to 6% ointment as needed.
    
    
  
  
  • For psoriasis and seborrheic dermatitis:
    
    • Adults and children—Use the 3 to 10% ointment as needed.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every three to five days.
    
    
  
  


• For pads dosage form:
  
  • For acne:
    
    • Adults and children—Use one to three times a day.
    
    
  
  


• For plaster dosage form:
  
  • For corns, calluses, common warts, or plantar warts:
    
    • Adults and children—Use one time a day or one time every other day.
    
    
  
  


• For shampoo dosage form:
  
  • For dandruff or seborrheic dermatitis of the scalp:
    
    • Adults and children—Use on the scalp one or two times a week.
    
    
  
  


• For soap dosage form:
  
  • For acne:
    
    • Adults and children—Use as needed.
    
    
  
  


• For topical solution dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 2% topical solution one to three times a day.
    
    
  
  
  • For common warts and plantar warts:
    
    • Adults and children—Use the 5 to 27% topical solution one or two times a day.
    
    
  
  
  • For corns and calluses:
    
    • Adults and children—Use the 12 to 27% topical solution one or two times a day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Occlusal-HP

When using salicylic acid, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

• Abrasive soaps or cleansers


• Alcohol-containing preparations


• Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])


• Cosmetics or soaps that dry the skin


• Medicated cosmetics


• Other topical medicine for the skin

To use any of the above preparations on the same affected area as salicylic acid may cause severe irritation of the skin.

Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances. These could be symptoms of a serious condition called salicylate toxicity, especially in children under 12 years of age and patients with kidney or liver problems.

Occlusal-HP Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Skin irritation not present before use of this medicine (moderate or severe)

Frequency not known

• Dryness and peeling of skin


• flushing


• redness of skin


• unusually warm skin

Symptoms of salicylic acid poisoning

• Confusion


• diarrhea


• dizziness


• fast or deep breathing


• headache (severe or continuing)


• hearing loss


• lightheadedness


• nausea


• rapid breathing


• ringing or buzzing in ears (continuing)


• severe drowsiness


• stomach pain


• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Skin irritation not present before use of this medicine (mild)


• stinging

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Occlusal-HP Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Occlusal-HP Topical resources

• Occlusal-HP Topical Side Effects (in more detail)
• Occlusal-HP Topical Use in Pregnancy & Breastfeeding
• Occlusal-HP Topical Drug Interactions
• Occlusal-HP Topical Support Group
• 0 Reviews for Occlusal-HP Topical - Add your own review/rating

Compare Occlusal-HP Topical with other medications

• Acne
• Warts

Fatral

Fatral may be available in the countries listed below.

Ingredient matches for Fatral

Sertraline

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Fatral in the following countries:

• Indonesia

International Drug Name Search

Finasterida Pensa

Finasterida Pensa may be available in the countries listed below.

Ingredient matches for Finasterida Pensa

Finasteride

Finasteride is reported as an ingredient of Finasterida Pensa in the following countries:

• Spain

International Drug Name Search

Farnormin

Farnormin may be available in the countries listed below.

Ingredient matches for Farnormin

Atenolol

Atenolol is reported as an ingredient of Farnormin in the following countries:

• Indonesia

International Drug Name Search

Fasicare

Fasicare may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Fasicare

Triclabendazole

Triclabendazole is reported as an ingredient of Fasicare in the following countries:

• Australia

International Drug Name Search

Alcosanal

Alcosanal may be available in the countries listed below.

Ingredient matches for Alcosanal

Chlorocarvacrol

Chlorocarvacrol is reported as an ingredient of Alcosanal in the following countries:

• Sweden

Oleic Acid

Oleic Acid sodium (a derivative of Oleic Acid) is reported as an ingredient of Alcosanal in the following countries:

• Sweden

International Drug Name Search

Finasteride Hexal

Finasteride Hexal may be available in the countries listed below.

Ingredient matches for Finasteride Hexal

Finasteride

Finasteride is reported as an ingredient of Finasteride Hexal in the following countries:

• Greece


• Italy

International Drug Name Search

Fastject

Fastject may be available in the countries listed below.

Ingredient matches for Fastject

Epinephrine

Epinephrine is reported as an ingredient of Fastject in the following countries:

• Luxembourg

International Drug Name Search

Fast Powder

Fast Powder may be available in the countries listed below.

Ingredient matches for Fast Powder

Bacitracin

Bacitracin zinc salt (a derivative of Bacitracin) is reported as an ingredient of Fast Powder in the following countries:

• Oman

Neomycin

Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Fast Powder in the following countries:

• Oman

International Drug Name Search

PreNexa

Pronunciation: pree-NATE-al MUL-tee-VYE-ta-mins/VYE-ta-min A/MIN-er-als/EYE-urn/FOE-lik AS-id/DOK-ue-sate SOE-dee-um
Generic Name: Prenatal Multivitamin without Vitamin A with Minerals, Iron, Folic Acid, Docusate Sodium, and DHA
Brand Name: Examples include PreNexa and Taron-Prex

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call your local poison control center or your doctor at once.

PreNexa is used for:

Treating or preventing a lack of vitamins or minerals before, during, and after pregnancy and while breast-feeding. It may also be used for other conditions as determined by your doctor.

PreNexa is a vitamin, mineral, iron, folic acid, docosahexaenoic acid (DHA), and stool softener combination. It works by providing vitamins and minerals to the body to help meet nutritional requirements. The stool softener helps prevent constipation that may occur with iron products.

Do NOT use PreNexa if:

• you are allergic to any ingredient in PreNexa, including soy, fish, or fish oil


• you have hemochromatosis (a disorder of iron metabolism)

Contact your doctor or health care provider right away if any of these apply to you.

Before using PreNexa:

Some medical conditions may interact with PreNexa. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have stomach or intestinal problems (eg, colitis, Crohn disease, diverticulitis, peptic ulcer), blood problems (eg, pernicious anemia, other types of anemia, porphyria), bleeding problems (eg, hemophilia), or a history of kidney stones


• if you have had multiple blood transfusions


• if you are taking mineral oil

Some MEDICINES MAY INTERACT with PreNexa. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Oral anticoagulants (eg, warfarin) because the risk of bleeding may be increased by PreNexa


• Fluorouracil because its actions and the risk of its side effects may be increased by PreNexa


• Hydantoins (eg, phenytoin), methyldopa, or penicillamine because their effectiveness may be decreased by PreNexa

This may not be a complete list of all interactions that may occur. Ask your health care provider if PreNexa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use PreNexa:

Use PreNexa as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take PreNexa by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take PreNexa by mouth with a full glass of water (8 oz/240 mL).


• Do not take an antacid within 1 hour before or 2 hours after you take PreNexa.


• Avoid taking PreNexa with dairy products; they may interfere with the absorption of the iron in PreNexa.


• Many medicines (eg, used for infection, blood pressure, low blood platelets, osteoporosis, thyroid problems) should not be taken at the same time as PreNexa; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of PreNexa should be separated from your dose of any of your other medicines.


• If you miss a dose of PreNexa, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use PreNexa.

Important safety information:

• PreNexa may discolor the stools. This is normal and not a cause for concern.


• PreNexa has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.


• PreNexa has pyridoxine (vitamin B₆) in it. Before you start any new medicine, check the label to see if it has pyridoxine (vitamin B₆) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Some brands of PreNexa may contain fish oil or soy. If you have had an allergic reaction to fish, fish oil, or soy, ask your pharmacist if your brand contains fish oil.


• This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.


• Do not take large doses of vitamins while you use PreNexa unless your doctor tells you to.


• PREGNANCY and BREAST-FEEDING: PreNexa is intended for use during pregnancy and breast-feeding. If you are or will be breast-feeding while you use PreNexa, check with your doctor.

Possible side effects of PreNexa:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or discolored stools; diarrhea; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stools; stomach pain or cramping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: PreNexa side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; chest pain; lack of feeling alert; loss of balance; seizure; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or weakness; unusually pale skin; weak pulse.

Proper storage of PreNexa:

Store PreNexa at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep PreNexa out of the reach of children and away from pets.

General information:

• If you have any questions about PreNexa, please talk with your doctor, pharmacist, or other health care provider.


• PreNexa is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about PreNexa. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More PreNexa resources

• PreNexa Side Effects (in more detail)
• PreNexa Use in Pregnancy & Breastfeeding
• PreNexa Drug Interactions
• PreNexa Support Group
• 2 Reviews for PreNexa - Add your own review/rating

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