DRUGS & SUPPLEMENTS

Pamine Forte

Name: Pamine Forte drug & pharmaceuticals. Available Forms, Doses, Prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Description
Clinical pharmacology
Pharmacokinetics
Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Drug abuse and dependence
Overdosage
Dosage and administration
How supplied
References
Pamine Forte reviews

DESCRIPTION

Pamine Forte 2.5 mg Tablets/Methscopolamine Bromide 5 mg Tablets contain Pamine Forte, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Pamine Forte melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform.

The chemical name for Pamine Forte is 3-Oxa-9-azoniatricyclo [3.3.1.0^2,4] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7(S)-(1α, 2β, 4β, 5α, 7β)]- and the molecular weight is 398.30.

The structural formula is represented below:

Pamine Forte 2.5 mg Tablets for oral administration contain 2.5 mg of Pamine Forte. Pamine Forte 5 mg Tablets for oral administration contain 5 mg of Pamine Forte.

Inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.

Contains no lactose.

Pamine Forte chemical structure

CLINICAL PHARMACOLOGY

Pamine Forte is an anticholinergic agent which possesses most of the pharmacologic actions of that drug class. These include reduction in volume and total acid content of gastric secretion, inhibition of gastrointestinal motility, inhibition of salivary excretion, dilation of the pupil and inhibition of accommodation with resulting blurring of vision. Large doses may result in tachycardia.

PHARMACOKINETICS

Pamine Forte is a quaternary ammonium derivative of scopolamine. As a class, these agents are poorly and unreliably absorbed.^1,2 Total absorption of quaternary ammonium derivatives of the alkaloids is 10-25%. Rate of absorption is not available. Quaternary ammonium salts have limited absorption from intact skin, and conjunctival penetration is poor.¹ Little is known of the fate and excretion of most of these agents.¹ Following oral administration, drug effects appear in about one hour and persist for 4 to 6 hours.² Pamine Forte has limited ability to cross the blood-brain barrier.^3,4,5 The drug is excreted primarily in the urine and bile, or as unabsorbed drug in feces.² There is no data on the presence of methscopolamine in breast milk; traces of atropine have been found after administration of atropine.¹

INDICATIONS AND USAGE

Adjunctive therapy for the treatment of peptic ulcer.

Pamine Forte HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.

CONTRAINDICATIONS

Glaucoma; obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (e.g., pyloroduodenal stenosis); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

Pamine Forte 2.5 mg Tablets/Methscopolamine Bromide 5 mg Tablets are contraindicated in patients who are hypersensitive to Pamine Forte or related drugs.

WARNINGS

In the presence of high environmental temperature, heat prostration (fever and heatstroke due to decreased sweating) can occur with drug use.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.

Pamine Forte may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

With overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis.

PRECAUTIONS

1. General precautions

Use Pamine Forte 2.5 mg Tablets/Methscopolamine Bromide 5 mg Tablets with caution in the elderly and in all patients with: autonomic neuropathy; hepatic or renal disease; or ulcerative colitis–large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason precipitate or aggravate “toxic megacolon,” a serious complication of the disease.

The drug also should be used with caution in patients having hyperthyroidism, coronary heart disease, congestive heart failure, tachyrhythmia, tachycardia, hypertension, or prostatic hypertrophy.

2. Information for patient

3. Laboratory tests

Progress of the peptic ulcer under treatment should be followed by upper gastrointestinal contrast radiology or endoscopy to insure healing. Stool tests for occult blood and blood hemoglobin or hematocrit values should be followed to rule out bleeding from the ulcer.

4. Drug interactions

Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of Pamine Forte.

5. Carcinogenesis, mutagenesis, impairment of fertility

No long-term studies in animals have been performed to evaluate carcinogenic potential.

6. Pregnancy

Teratogenic effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Pamine Forte. It also is not known whether Pamine Forte can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pamine Forte should be given to a pregnant woman only if clearly needed.

7. Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pamine Forte is administered to a nursing woman.

Anticholinergic drugs may suppress lactation.

8. Pediatric use

Safety and efficacy in children have not been established.

ADVERSE REACTIONS

The following adverse reactions have been observed, but there is not enough data to support an estimate of frequency.

Cardiovascular: Tachycardia, palpitation.

Allergic: Severe allergic reaction or drug idiosyncrasies including anaphylaxis.

CNS: Headaches, nervousness, mental confusion, drowsiness, dizziness.

Special Senses: Blurred vision, dilation of the pupil, cycloplegia, increased ocular tension, loss of taste.

Renal: Urinary hesitancy and retention.

Gastrointestinal: Nausea, vomiting, constipation, bloated feeling.

Dermatologic: Decreased sweating, urticaria and other dermal manifestations.

Miscellaneous: Xerostomia, weakness, insomnia, impotence, suppression of lactation.

DRUG ABUSE AND DEPENDENCE

Not applicable.

OVERDOSAGE

The symptoms of overdosage with Pamine Forte 2.5 mg Tablets/Methscopolamine Bromide 5 mg Tablets progress from intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma.

Measures to be taken are (1) induction of emesis and (2) injection of physostigmine 0.5 to 2 mg intravenously, and repeated as necessary up to a total of 5 mg. Fever maybe treated symptomatically (alcohol sponging, ice packs). Excitement of a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

The oral LD₅₀ in rats is 1,352 to 2,617 mg/kg.

No data is available on the dialyzability of Pamine Forte.

DOSAGE AND ADMINISTRATION

The average dosage of Pamine Forte Tablets is 2.5 mg one-half hour before meals and 2.5 to 5 mg at bedtime. A starting dose of 12.5 mg daily will be clinically effective in most patients without the production of appreciable side effects.

If the patient is experiencing symptoms such as severe abdominal pain or cramping which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5 mg one-half hour before meals and at bedtime. If very unpleasant side effects develop promptly, the daily dosage should be reduced. If neither symptomatic relief nor side effects appear, the daily dosage may be increased. Some patients have tolerated 30 mg daily with no unpleasant reactions.

Patients whose dosage has been reduced to eliminate or modify side effects often continue to show adequate response both subjectively in relief of symptoms and objectively as measured by antisecretory effects.

The ultimate aim of therapy is to arrive at a dosage which provides maximal clinical effectiveness with a minimum of unpleasant side effects. Many patients report no side effects on a dosage which gives complete relief of symptoms. On the other hand, some patients have reported severe side effects without appreciable symptomatic relief. Such patients must be considered unsuited for this therapy. Usually they have been or will prove to be similarly intolerant to other anticholinergic drugs. If Pamine Forte is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.

HOW SUPPLIED

Pamine Forte 2.5 mg Tablets are available as white, round tablets, debossed with “F” on one side and “482” on the other side, in the following package size:

Bottles of 100 (NDC 0168-0482-99)

Pamine Forte 5 mg Tablets are available as white, oval tablets, debossed with “F” on one side and “483” on the other side, in the following package size:

Dose Pack (5 blisters of 12 tablets)

Box of 60 (NDC 0168-0483-60)

Store at 15°-30°C (59°-86°F).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

REFERENCES

Gilman A, Gilman AB, Goodman LA, eds. The Pharmacological Basis of Therapeutics. 6th ed. New York: MacMillan Publishing Company, 1980.
American Hospital Formulary Service. American Society of Hospital Pharmacists. Bethesda, Maryland.
Domino EF, Corasen G. Central and Peripheral Effects of Muscarinic Cholinergic Blocking Agents in Man. Anesthesiology. 1967;28:568-574.
Mogensen L, Orinius E. Arrhythmic Complications after Parasympathetic Treatment of Bradyarrhythmias in a Coronary Care Unit. Acta Med Scand.1971;190:495-498.
Neeld JB Jr. et al. Cardiac Rate and Rhythm Changes with Atropine and Methscopolamine. Clin Pharmacol Ther.1975;17(3): 290-295.

Manufactured for:

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, New York 11747

Manufactured by:

Mikart, Inc.

Atlanta, GA 30318 USA

Code 935C00

Rev. 02/12

IL295B

R02/12

NDC 0168-0482-99

fougera^®

Pamine Forte

2.5 mg Tablets

100 Tablets

Rx only

100 count bottle

NDC 0168-0483-60

60 Tablets

(5 blister cards of 12 tablets each)

fougera^®

Pamine Forte 5 mg

Tablets

DOES PACK Dispense As One Unit

Rx only

60 count container

Pamine Forte pharmaceutical active ingredients containing related brand and generic drugs:

Methscopolamine Bromide

Pamine Forte available forms, composition, doses:

Tablets; Oral; Methscopolamine Bromide 5 mg

Pamine Forte destination | category:

Human:
Quarternary anticholinergics

Pamine Forte Anatomical Therapeutic Chemical codes:

A03BB03 - Methylscopolamine
S01FA03 - Methylscopolamine

Pamine Forte pharmaceutical companies:

References

Dailymed."METHSCOPOLAMINE BROMIDE TABLET [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Pamine Forte?

Depending on the reaction of the Pamine Forte after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Pamine Forte not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Pamine Forte addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Pamine Forte, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Pamine Forte consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.