Rejunik

Contraindications

Hypersensitivity to Pregabalin (Rejunik) and methylcobalamin.

Use in pregnancy & lactation: Safety and efficacy have not been established in pregnancy and lactation.

Use in children: Safety and efficacy have not been established in children.

Undesirable effects

Fatigue, dizziness, ataxia, wt gain, peripheral edema, dry mouth & somnolence.

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients >12 years of age with epilepsy.

Neuralgia: Peripheral and diabetic neuropathies, intercostals neuralgia, entrapment neuropathy.

Name of the medicinal product

Rejunik

Qualitative and quantitative composition

Each hard-gelatin capsule contains Pregabalin (Rejunik) 75 mg and methylcobalamin 750 mcg.

Dosage (Posology) and method of administration

Adults: 1 cap 3 times daily.

Children: Rejunik cap is not recommended.

Interaction with other medicinal products and other forms of interaction

Pregabalin (Rejunik): In vitro Studies: Pregabalin (Rejunik), at concentrations that were, in general, 10-times those attained in clinical trials, does not inhibit human CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 enzyme systems. In vitro drug interaction studies demonstrate that Pregabalin (Rejunik) does not induce CYP1A2 and CYP3A4 activity. Therefore, an increase in the metabolism of co-administered CYP1A2 substrates (eg, theophylline, caffeine) or CYP3A4 substrates (eg, midazolam, testosterone) is not anticipated. The drug interaction studies described in this section were conducted in healthy adults and across various patient populations.

Oral Contraceptive: Pregabalin (Rejunik) co-administered (200 mg 3 times daily) had no effect on the steady-state pharmacokinetics of norethidrone and ethinyl estradiol (1 mg/3 mcg, respectively) in healthy subjects.

Lorazepam: Multiple-dose administration of Pregabalin (Rejunik) (300 mg twice daily) in healthy subjects had no effect on the rate and extent of lorazepam single-dose pharmacokinetics, and single-dose administration of lorazepam (1 mg) had no effect on the steady-state pharmacokinetics of Pregabalin (Rejunik).

Oxycodone: Multiple-dose administration of Pregabalin (Rejunik) (300 mg twice daily) in healthy patients had no effect on the rate and extent of oxycodone single-dose pharmacokinetics. Single-dose administration of oxycodone 10 mg had no effect on the steady-state pharmacokinetics of Pregabalin (Rejunik).

Ethanol: Multiple-dose administration of Pregabalin (Rejunik) (300 mg twice daily) in healthy patients had no effect on the rate and extent of ethanol single-dose pharmacokinetics, and single-dose administration of ethanol 0.7 g/kg had no effect on the steady-state pharmacokinetics of Pregabalin (Rejunik).

Phenytoin, Carbamazepine, Valproic Acid and Lamotrigine: Steady-state trough plasma concentrations of phenytoin, carbamazepine and carbamazepine-10,11-epoxide, valproic acid and lamotrigine were not affected by concomitant Pregabalin (Rejunik) (200 mg 3 times daily) administration.

Methylcobalamin: Well tolerated, no significant drug interaction reported.