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What is the most important information I should know about Frida?
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 Frida to prevent seizures, keep taking the medication even if you feel fine.
Do not stop using Frida 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 Frida.
Do not change your dose of Frida 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 Frida. Any medical care provider who treats you should know that you take seizure medication.
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What are the possible side effects of Frida?
The Frida clinical programme involved over 8900 patients who were exposed to Frida, 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 Frida and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from Frida 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 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<l/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 as Frequency not known in italics in the table below.
After discontinuation of short-term and long-term treatment with Frida 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 Frida, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
Neuropathic Pain: Frida is indicated for the treatment of neuropathic pain in adults, including neuropathic pain associated with spinal cord injury.
Epilepsy: Frida is indicated as adjunctive therapy in adults with partial seizures, with or without secondary generalization.
Generalized Anxiety Disorder: Frida is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.
Fibromyalgia: Frida is indicated for the management of fibromyalgia.
Frida is used with other medicines to help control partial seizures (convulsions) in the treatment of epilepsy. Frida will not cure epilepsy and will only work to control seizures for as long as you continue to take it.
Frida is also used for postherpetic neuralgia (pain that occurs after shingles) and pain caused by nerve damage from diabetes or a spinal cord injury. It is used to treat a condition called fibromyalgia (muscle pain and stiffness).
Frida works in the central nervous system (CNS) to control seizures and pain. It is an anticonvulsant and neuropathic pain agent.
Frida is available only with your doctor's prescription.
Each capsule contains the following inactive ingredients: Mannitol, maize starch and talc.
Frida is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23.
Frida 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.
Use Frida solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Frida solution.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsFibromyalgia (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 UsesCough, chronic refractory
Data from a limited number of patients in a controlled trial suggest that Frida 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, Frida 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.
The dose range is 150 to 600 mg per day given in either two or three divided doses.
Epilepsy: Frida 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.
Frida 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 Frida: In accordance with current clinical practice, if Frida 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: Frida is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As Frida 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.
Frida is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the Frida 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 Frida 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 Frida due to a decreased renal function.
Administration: Frida Sandoz may be taken with or without food.
Frida Sandoz is for oral use only.
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What other drugs will affect Frida?
Since Frida is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro and in vivo studies showed that Frida is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between Frida and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between Frida and commonly used antiepileptic drugs.
PharmacodynamicsMultiple oral doses of Frida were co-administered with oxycodone, lorazepam, or ethanol. Although no pharmacokinetic interactions were seen, additive effects on cognitive and gross motor functioning were seen when Frida was co-administered with these drugs. No clinically important effects on respiration were seen.
Drug Abuse And DependenceControlled SubstanceFrida is a Schedule V controlled substance.
Frida is not known to be active at receptor sites associated with drugs of abuse. As with any CNS active drug, carefully evaluate patients for history of drug abuse and observe them for signs of Frida misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior).
AbuseIn a study of recreational users (N=15) of sedative/hypnotic drugs, including alcohol, Frida (450 mg, single dose) received subjective ratings of “good drug effect,” “high” and “liking” to a degree that was similar to diazepam (30 mg, single dose). In controlled clinical studies in over 5500 patients, 4 % of Frida-treated patients and 1 % of placebo-treated patients overall reported euphoria as an adverse reaction, though in some patient populations studied, this reporting rate was higher and ranged from 1 to 12%.
DependenceIn clinical studies, following abrupt or rapid discontinuation of Frida, some patients reported symptoms including insomnia, nausea, headache or diarrhea, consistent with physical dependence. In the postmarketing experience, in addition to these reported symptoms there have also been reported cases of anxiety and hyperhidrosis.
