Gaba-PM Uses

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• Gaba-PM indications
• Uses of Gaba-PM in details
• Gaba-PM description
• Gaba-PM dosage
• Gaba-PM interactions
• Gaba-PM side effects
• Gaba-PM contraindications

What is Gaba-PM?

Gaba-PM (Gaba-PM) is an anti-epileptic drug, also called an anticonvulsant. Gaba-PM works by slowing down nerve impulses in the brain and affects chemicals that send pain signals across the nervous system.

Gaba-PM is a prescription medicine used to treat pain caused by damaged nerves in people with diabetes (diabetic neuropathy). Gaba-PM is also used to treat pain caused by damaged nerves (neuropathic pain) that follows healing of shingles (herpes zoster). This condition is called post-herpetic neuralgia.

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It is not known if Gaba-PM is effective when used for the treatment of fibromyalgia, or when taken with other seizure medicines for adults with partial onset seizures.

Gaba-PM is supplied as extended-release tablets in the following strengths: 82.5 mg, 165 mg, and 330 mg.

Gaba-PM indications

Neuropathic Pain: Gaba-PM is indicated for the treatment of neuropathic pain in adults, including neuropathic pain associated with spinal cord injury.

Epilepsy: Gaba-PM is indicated as adjunctive therapy in adults with partial seizures, with or without secondary generalization.

Generalized Anxiety Disorder: Gaba-PM is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.

Fibromyalgia: Gaba-PM is indicated for the management of fibromyalgia.

How should I use Gaba-PM?

Use Gaba-PM solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gaba-PM solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Gaba-PM solution refilled.
• Take Gaba-PM solution by mouth with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Taking Gaba-PM solution at the same time each day will help you remember to take it.
• Take Gaba-PM solution on a regular schedule to get the most benefit from it.
• If you miss a dose of Gaba-PM solution, 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 Gaba-PM solution.

Uses of Gaba-PM in details

Use: Labeled Indications

Fibromyalgia (immediate release only): Management of fibromyalgia

Neuropathic pain associated with diabetic peripheral neuropathy (immediate release and extended release): Management of neuropathic pain associated with diabetic peripheral neuropathy

Neuropathic pain associated with spinal cord injury (immediate release only): Management of neuropathic pain associated with spinal cord injury

Postherpetic neuralgia (immediate release and extended release): Management of postherpetic neuralgia

Seizures, focal (partial) onset (immediate release only): Adjunctive therapy in patients ≥1 month of age with focal onset (partial-onset) seizures

Off Label Uses

Cough, chronic refractory

Data from a limited number of patients in a controlled trial suggest that Gaba-PM in combination with speech pathology therapy may be beneficial for the treatment of refractory chronic cough.

Based on the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) position statement on menopause, the Endocrine Society guideline on the treatment of symptoms of menopause, and the North American Menopause Society (NAMS) position statement on nonhormonal management of menopause-associated vasomotor symptoms, Gaba-PM is an effective and recommended alternative for the management of vasomotor symptoms associated with menopause in patients with contraindications to hormonal therapy or who prefer not to use hormonal therapy.

Gaba-PM description

Each capsule contains the following inactive ingredients: Mannitol, maize starch and talc.

Gaba-PM is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C₈H₁₇NO₂ and the molecular weight is 159.23.

Gaba-PM is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05 M phosphate buffer) at pH 7.4 is -1.35.

Gaba-PM dosage

The dose range is 150 to 600 mg per day given in either two or three divided doses.

Epilepsy: Gaba-PM treatment can be started with a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week.

Generalised Anxiety Disorder: The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly.

Gaba-PM treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week, the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week.

Discontinuation of Gaba-PM: In accordance with current clinical practice, if Gaba-PM has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication.

Patients with Renal Impairment: Gaba-PM is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As Gaba-PM clearance is directly proportional to creatinine clearance, dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CrCl), as indicated in Table 1 determined using the following formula.

Gaba-PM is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the Gaba-PM daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4-hour haemodialysis treatment.

Patients with Hepatic Impairment: No dose adjustment is required for patients with hepatic impairment.

Children: The safety and efficacy of Gaba-PM Sandoz in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. No data are available.

Elderly (over 65 years of age): Elderly patients may require a dose reduction of Gaba-PM due to a decreased renal function.

Administration: Gaba-PM Sandoz may be taken with or without food.

Gaba-PM Sandoz is for oral use only.

Gaba-PM interactions

See also:
What other drugs will affect Gaba-PM?

Since Gaba-PM is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (<2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro and is not bound to plasma proteins, it is unlikely to produce or be subject to pharmacokinetic interactions.

Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between Gaba-PM and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol. Population pharmacokinetic analysis indicated that the oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on Gaba-PM clearance.

Co-administration of Gaba-PM with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance. Gaba-PM may potentiate the effects of ethanol and lorazepam. In controlled clinical trials, multiple oral doses of Gaba-PM co-administered with oxycodone, lorazepam or ethanol did not result in clinically important effects on respiration. In the post-marketing experience, there are reports of respiratory failure and coma in patients taking Gaba-PM and other CNS depressant medications. Gaba-PM appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone.

No specific pharmacodynamic interaction studies were conducted in elderly volunteers.

Gaba-PM side effects

See also:
What are the possible side effects of Gaba-PM?

The Gaba-PM clinical program involved over 8900 patients who were exposed to Gaba-PM, of whom over 5600 were in double-blind placebo-controlled trials. The most commonly reported adverse reactions were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity. In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving Gaba-PM and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from Gaba-PM treatment groups were dizziness and somnolence.

In Table 2 all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The adverse reactions listed may also be associated with the underlying disease and/or concomitant medicinal products.

In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, CNS adverse reactions and especially somnolence was increased.

Additional reactions reported from post-marketing experience are included in italics in Table 2.

After discontinuation of short-term and long-term treatment with Gaba-PM withdrawal symptoms have been observed in some patients. The following reactions have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, pain, hyperhidrosis and dizziness, suggestive of physical dependence. The patient should be informed about this at the start of the treatment.

Concerning discontinuation of long-term treatment of Gaba-PM, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.

Gaba-PM contraindications

See also:
What is the most important information I should know about Gaba-PM?

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

If you are taking Gaba-PM to prevent seizures, keep taking the medication even if you feel fine.

Do not stop using Gaba-PM without first talking to your doctor, even if you feel fine. You may have increased seizures or withdrawal symptoms such as headache, sleep problems, nausea, and diarrhea. Ask your doctor how to avoid withdrawal symptoms when you stop using Gaba-PM.

Do not change your dose of Gaba-PM without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

Wear a medical alert tag or carry an ID card stating that you take Gaba-PM. Any medical care provider who treats you should know that you take seizure medication.

Active ingredient matches for Gaba-PM:

Pregabalin in India.

Mecobalamin in India.

References

1. DailyMed. "PREGABALIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "Pregabalin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "Pregabalin". http://www.drugbank.ca/drugs/DB00230 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology