Dygab Uses

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• Dygab indications
• Uses of Dygab in details
• Dygab description
• Dygab dosage
• Dygab interactions
• Dygab side effects
• Dygab contraindications

What is Dygab?

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

Dygab is a prescription medicine used to treat pain caused by damaged nerves in people with diabetes (diabetic neuropathy). Dygab 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 Dygab is effective when used for the treatment of fibromyalgia, or when taken with other seizure medicines for adults with partial onset seizures.

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

Dygab indications

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

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

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

Fibromyalgia: Dygab is indicated for the management of fibromyalgia.

How should I use Dygab?

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

• Dygab solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dygab solution refilled.
• Take Dygab 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 Dygab solution at the same time each day will help you remember to take it.
• Take Dygab solution on a regular schedule to get the most benefit from it.
• If you miss a dose of Dygab 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 Dygab solution.

Uses of Dygab 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 Dygab 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, Dygab 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.

Dygab description

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

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

Dygab 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.

Dygab dosage

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

Epilepsy: Dygab 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.

Dygab 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 Dygab: In accordance with current clinical practice, if Dygab 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: Dygab is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As Dygab 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.

Dygab is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the Dygab 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 Dygab 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 Dygab due to a decreased renal function.

Administration: Dygab Sandoz may be taken with or without food.

Dygab Sandoz is for oral use only.

Dygab interactions

See also:
What other drugs will affect Dygab?

Since Dygab 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 Dygab 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 Dygab clearance.

Co-administration of Dygab with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance. Dygab may potentiate the effects of ethanol and lorazepam. In controlled clinical trials, multiple oral doses of Dygab 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 Dygab and other CNS depressant medications. Dygab 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.

Dygab side effects

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What are the possible side effects of Dygab?

The Dygab clinical program involved over 8900 patients who were exposed to Dygab, 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 Dygab and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from Dygab 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 Dygab 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 Dygab, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.

Dygab contraindications

See also:
What is the most important information I should know about Dygab?

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 Dygab to prevent seizures, keep taking the medication even if you feel fine.

Do not stop using Dygab 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 Dygab.

Do not change your dose of Dygab 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 Dygab. Any medical care provider who treats you should know that you take seizure medication.

Active ingredient matches for Dygab:

Pregabalin in Pakistan.

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