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PREGABALIN is a brand name for Pregabalin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................ 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Patients who are hypersensitive to pregabalin or to any ingredient in the formulation or component of the container. WARNINGS AND PRECAUTIONS Angioedema There have been post-marketing reports of angioedema in patients, some without reported previous history/episode(s), during initial/acute and chronic treatment with pregabalin.
Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), neck, throat, and larynx/upper airway. There have been reports of life-threatening angioedema with respiratory compromise requiring emergency treatment.
Some of these patients did not have reported previous history/episode(s) of angioedema. PREGABALIN CAPSULES should be immediately discontinued in patients with these symptoms. During the pre-marketing assessment of pregabalin in clinical trials, angioedema was reported as a rare reaction (see ADVERSE REACTIONS, Less Common Clinical Trial Adverse Reactions and Post-Marketing Adverse Drug Reactions).
Caution should be exercised when prescribing PREGABALIN CAPSULES to patients with previous history/episode(s) of angioedema and related events. In addition, patients who are taking other drugs associated with angioedema (eg, ACE-inhibitors) may be at increased risk of developing this condition.
Hypersensitivity There have been post-marketing reports of hypersensitivity reactions (eg, skin redness, blisters, hives, rash, dyspnea, and wheezing). Pregabalin should be discontinued immediately if such symptoms occur (see Post-Marketing Adverse Drug Reactions).
Renal Failure In both clinical trials of various indications and post-marketing database, there are reports of patients, with or without previous history, experiencing renal failure while receiving pregabalin alone or in combination with other medications.
Discontinuation of pregabalin should be considered as it has shown reversibility of this event in some cases. Caution is advised when prescribing pregabalin to the elderly or those with any degree of renal impairment (see Special Populations, Renal; Abrupt or Rapid Discontinuation; ADVERSE REACTIONS, Post- Marketing Adverse Drug Reactions; and DOSAGE AND ADMINISTRATION).
Tumorigenic Potential In standard preclinical in vivo lifetime carcinogenicity studies of pregabalin, a high incidence of hemangiosarcoma was identified in two different strains of mice (see Preclinical Toxicology). The clinical significance of this finding is uncertain.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pregabalin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Clinical experience during pregabalin’s premarketing development provides no direct means to assess its potential for inducing tumors in humans. Page 5 of 61 In clinical studies across various patient populations, comprising 6396 patient-years of exposure in 8666 patients ranging in age from 12 to 100 years, new or worsening-preexisting tumors were reported in 57 patients.
The most common malignant tumor diagnosed was skin carcinoma (17 patients) followed by breast carcinoma (8 patients), prostatic carcinoma (6 patients), carcinoma not otherwise specified (6 patients), and bladder carcinoma (4 patients).
Without knowledge of the background incidence and recurrence in similar populations not treated with pregabalin, it is impossible to know whether the incidence seen in these cohorts is or is not affected by treatment. 5% placebo). Approximately 1% of pregabalin-treated patients discontinued treatment due to vision-related adverse events (primarily blurred vision).
Of the patients who did not withdraw, the blurred vision resolved with continued dosing in approximately half of the cases (see Post- Marketing Adverse Drug Reactions). Prospectively planned ophthalmologic testing, including visual acuity testing, formal visual field testing and dilated funduscopic examination, was performed in over 3600 patients.
In these patients, visual acuity was reduced in 7% of patients treated with pregabalin, and 5% of placebo- treated patients. Visual field changes were detected in 13% of pregabalin-treated, and 12% of placebo-treated patients. Funduscopic changes were observed in 2% of pregabalin-treated and 2% of placebo-treated patients.
At this time, clinical significance of the ophthalmologic findings is unknown. Patients should be informed that if changes in vision occur, they should notify their physician. If visual disturbance persists, further assessment, including discontinuation of pregabalin, should be considered.
More frequent assessments should be considered for patients who are already routinely monitored for ocular conditions. Peripheral Edema PREGABALIN CAPSULES may cause peripheral edema. In controlled peripheral neuropathic pain and fibromyalgia clinical trials, pregabalin treatment caused peripheral edema in 9% of patients compared with 3% of patients in the placebo group.
3% of placebo patients withdrew due to peripheral edema (see ADVERSE REACTIONS, Peripheral Edema). In controlled clinical trials of up to 13 weeks in duration of patients without clinically significant heart or peripheral vascular disease, there was no apparent association between peripheral edema and cardiovascular complications such as hypertension or congestive heart failure.
In the same trials, peripheral edema was not associated with laboratory changes suggestive of deterioration in renal or hepatic function. Higher frequencies of weight gain and peripheral edema were observed in patients taking both pregabalin and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone.
The majority of patients using thiazolidinedione antidiabetic agents in the overall safety database were participants in studies of pain associated with diabetic peripheral neuropathy. In Page 6 of 61 this population, peripheral edema was reported in 3% (2/60) of […]