Essividine

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

Adults

+ Combining with other antiepileptics drugs for the treatment of partial seizures: Begin dosing at 150 mg/day given in two divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg/day after one week. If needed, to a maximum dose of 600 mg/day after an additional 1 week interval.

+ Neuropathic pain associated with diabetic peripheral neuropathy: Begin dosing at 150 mg/day, may be increased to a maximum recommended dose 300 mg/day within 1 week. Increasing the dose does not increase the benefit but adds more ADRs (adverse reactions).

+ Postherpetic neuralgia : The recommended dose is 150 – 300 mg/day. Begin dosing at 150 mg/day, the dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient relief following 2 to 4 weeks of treatment with 300 mg/day, may be treated with up to 600mg/day. Dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily because of ADRs.

+ Generalized anxiety disorder: Begin dosing at 150 mg/day, may be increased gradually at weekly intervals of 150 mg to a maximum dose of 600 mg/day.

+ Fibromyalgia: Begin dosing at 150 mg/day, based on individual patient response and tolerability, the dose may be increased to 300 mg/day after 1 week, and if needed, the dose may be increased to 450 mg/day.

Children: The safety and efficacy of pregabalin in children have not been established.

Renal failure: Pregabalin dose adjustment based on creatinine clearance (ClCr), specifically as follows:

TID= Three divided doses; BID= Two divided doses; QD= Single daily dose

For patients undergoing hemodialysis, administer a supplemental dose (25 – 100 mg), immediately following every 4 hours of hemodialysis treatment.

Hepatic impairment: No dose adjustment is required.

Elderly: Elderly patients may require a dose reduction of pregabalin based on creatinine clearance (ClCr) in the table above. 

Method of administration

Essividine is for oral use, may be taken with or without food.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed

WARNINGS AND PRECAUTIONS

Conditions should be caution when taking the drug:

Pregabalin may cause peripheral edema. Higher frequencies of weight gain and peripheral edema were observed in patients taking both Essividine and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone. There was no apparent association between peripheral edema and cardiovascular complications (hypertension or congestive heart failure) ,and  deterioration in renal or hepatic function.

Angioedema may occur with initiation or chronic treatment with pregabalin. Specific symptoms include: swelling of the face, mouth (tongue, lips, gums), and neck (throat and larynx), which can sometimes be life-threatening. Pregabalin should be discontinued immediately in patients with these symptoms. Caution should be exercised when prescribing Essividine to patients with previous history of angioedema or who are also taking other drugs associated with angioedema (eg, ACE inhibitors).

Pregabalin has been associated with the central nervous system  including somnolence and dizziness, and can impair both the patient's physical and mental well-being. Accordingly, caution should be exercised in those who drive or operate machinery.

In the postmarketing experience, visual adverse effects have been reported, including decreased vision, blurred vision, sometimes transient. Therefore, discontinuation of pregabalin may result in
resolution or improvement of these visual symptoms.

Cases of renal failure have been reported. In some cases discontinuation of pregabalin did show reversibility of this
adverse reaction.

Pregabalin-associated weight gain was related to dose and duration of exposure; however, it did not appear to be associated with baseline BMI, gender, or age and was not limited to patients with edema. Although weight gain was not associated with clinically important changes in blood pressure in short-term controlled studies, the long-term cardiovascular effects of pregabalin-associated weight gain are unknown. In addition, pregabalin did not appear to be associated with loss of glycemic control.

Pregabalin may increase CPK (creatinine phosphokinase) and may cause paroxysmal globinuria (although rare). Patients should notify their doctor when symptoms such as pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or fever. Pregabalin treatment should be discontinued if myopathy is diagnosed or suspected.

Pregabalin should be tapered gradually over a minimum of one week before discontinued to avoid the increased frequency of epilepsy with generic antiepileptics.

Cases of abuse or dependence have been reported with pregabalin use. Therefore, caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of pregabalin abuse (development of tolerance, dose escalation, drug-seeking behaviour). Following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms
including insomnia, nausea, headache, anxiety, and diarrhea.

There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin. These adverse reactions have mostly been observed in elderly cardiovascular compromised patients during pregabalin treatment  Therefore, Pregabalin should be used with caution in these patients.

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

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. Patients and their family members (or caregivers) should be informed of this side effect and asked to notify their physician immediately of any warning signs such as the appearance or worsening of symptoms. depressive manifestations; unusual changes in personality, behaviour; suicidal tendencies or self-harm.

There have been post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, and constipation) in patients when pregabalin is used in combination with opioid analgesics. Cautions should be exercised when Essividine and opioid analgesics are used in combination, and measures to prevent constipation may be considered (especially in female patients and elderly).

Essividine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicinal product.

Fertility, pregnancy and lactation

Pregnancy: There are no adequate data from the use of pregabalin in pregnant women. Studies in animals have shown reproductive toxicity, the potential risk for humans is unknown. Therefore, Essividine should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).

Administer of the contraceptive method when the drug is used for female fertility.

Breast-feeding: Pregabalin is excreted into human milk. The effect of pregabalin on newborns/infants is unknown. Therefore, do not breastfeed the baby while taking this medicine. 

Effects on ability to operate machinery, working at height and other cases

Essividine may cause somnolence and dizziness. If it may influence, patients are advised not to operate machinery, drive, work at height or do other activities.

SHELF-LIFE

36 months from the manufacturing date. Do not use after the expiry date

Box of 4 blisters x 14 hard capsules.