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Pregabalin
Commercial name
PREGASTAR EX.R
Category
NEUROLOGICAL DRUGS
Chemical composition

Each extended-release, film-coated tablet contains 82.5 mg pregabalin

Each extended-release, film-coated tablet contains 165 mg pregabalin

Each extended-release, film-coated tablet contains 330 mg of pregabalin

Dosage Form
Extended realese&film coated tablets
Pharmaceutical group
Anticonvulsants and antiepileptics
Contraindications

- Hypersensitivity to pregabalin or any of the excipients used.

- Previous history of angioedema.

Drug interactions

- Because pregabalin is excreted unchanged in the urine, has little metabolism in humans (less than 2% of the dose recovered in the urine as metabolites), and is not bound to plasma proteins, its pharmacokinetics are unlikely to be influenced by other factors through metabolic reactions or Protein binding offset.

- Lorazepam, oxycodone: Increased cognitive and overall performance

- Fentanyl: occurrence of adverse side effects such as respiratory distress that may lead to death.

-Drug interaction may occur with diabetes medications (pioglitazone, rosiglitazone), and with blood pressure medications (ACE inhibitors).

Dosage and usage

 

- Neuropathic pain associated with diabetic peripheral neuropathy

- Postherpetic neuralgia.

- Neuropathic pain caused by myofascial pain and spinal cord injury.

- It may be used with other medicines to treat partial seizures in adults and children.

Neuropathic pain associated with diabetic peripheral neuropathy:

1 tablet, 165 mg once daily and increased to 330 mg once daily for 1 week based on individual patient response and tolerance. The maximum recommended dose of pregastar extended-release is 330 mg once daily.

Postherpetic neuralgia: starting with 165 mg once daily and increasing to 330 mg once daily within 1 week based on individual patient response and tolerance.

Patients with insufficient pain relief after 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate pregastar may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of discontinuation of treatment due to adverse reactions.

- Pregastar extended-release should be taken once daily, after an evening meal.

Regastar extended-release should be swallowed whole and should not be divided, crushed or chewed.

- When you stop taking brigastar mide-release, reduce the dose gradually over a period of at least 1 week.

Patients with Renal Impairment: Pregastar extended release is not recommended for patients with creatinine clearance (CLcr) less than 30 mL/min or who are on hemodialysis

Side Effect

Mood and behavior changes, depression, anxiety, panic attacks, sleep problems, aggression, hyperactivity, shortness of breath, bluish skin, lips and toes, bruising, skin ulcers, increased appetite, dizziness and drowsiness, swelling in the hands and feet, dry mouth, blurred vision

Marketing authorization number(s)

PREGASTAR 82.5 mg  EX.R film coated tablets...........( 354/ 2020 ).

PREGASTAR 165 mg  EX.R film coated tablets...........( 355/ 2020 ).

PREGASTAR 330 mg EX.R film coated tablets...........( 356/ 2020 ).

The nature and content of the packaging

A carton box containing 1 or 3 blisters, each one contains 10 ex.r film coated tablets.