Biotin/pregabalin/vitamin d3

Contraindications

See also:
What is the most important information I should know about Biotin?

SINEQUAN is contraindicated in individuals who have shown hypersensitivity to the drug. Possibility of cross sensitivity with other dibenzoxepines should be kept in mind.

SINEQUAN is contraindicated in patients with glaucoma or a tendency to urinary retention. These disorders should be ruled out, particularly in older patients.

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What is the most important information I should know about Pregabalin?

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 pregabalin to prevent seizures, keep taking the medication even if you feel fine.

Do not stop using pregabalin 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 pregabalin.

Do not change your dose of pregabalin 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 pregabalin. Any medical care provider who treats you should know that you take seizure medication.

See also:
What is the most important information I should know about Vitamin D3?

Contraindications for vitamin D analogues (Vitamin D2, Vitamin D3, Calcitriol, and Calcidiol)

Vitamin D should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of vitamin D in patients with known hypersensitivity to vitamin D (or drugs of the same class) or any of the inactive ingredients is contraindicated.

Undesirable effects

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What are the possible side effects of Biotin?

Adverse reactions associated with biotin supplementation are rare in the medical literature; however, urticaria and gastrointestinal upset have been reported. As with any oral treatment, if patients experience any adverse reactions or side effects, they should inform their physicians immediately and discontinue use.

See also:
What are the possible side effects of Pregabalin?

The pregabalin clinical programme involved over 8900 patients who were exposed to pregabalin, 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 pregabalin and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from pregabalin 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 pregabalin 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 pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.

See also:
What are the possible side effects of Vitamin D3?

Applies to cholecalciferol: oral capsule, oral capsule liquid filled, oral solution, oral tablet, oral tablet chewable, oral wafer

As well as its needed effects, cholecalciferol (the active ingredient contained in Vitamin D3) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking cholecalciferol, check with your doctor immediately:

Incidence not known:

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives or itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• tightness in the chest
• unusual tiredness or weakness

Therapeutic indications

skin disorders, biotin deficiency, digestive disorders

Neuropathic Pain: Pregabalin is indicated for the treatment of neuropathic pain in adults, including neuropathic pain associated with spinal cord injury.

Epilepsy: Pregabalin is indicated as adjunctive therapy in adults with partial seizures, with or without secondary generalization.

Generalized Anxiety Disorder: Pregabalin is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.

Fibromyalgia: Pregabalin is indicated for the management of fibromyalgia.

Vitamin D3 has an important role in energize the intestinal absorption for calcium and phosphor, to regulate their metabolism and balance in blood. It helps bone calcification. Deficiency of vitamin D3 in the body causes deficiency of the calcium in the bone, weakness of its resistance and deformity.

Biotin is a form of vitamin B found in foods. Biotin helps the body break down fats, carbohydrates, and other substances.

Biotin has been used in alternative medicine as a likely effective aid in treating or preventing biotin deficiency. Biotin deficiency can be caused by malnutrition, rapid weight loss, long-term tube feeding, and other medical conditions.

Biotin has also been used to treat seborrhea (skin rash) in babies. However, research has shown that biotin may not be effective in treating this condition.

Other uses not proven with research have included treating brittle nails or thinning hair, diabetes, nerve pain, and other conditions.

It is not certain whether biotin is effective in treating any medical condition. Medicinal use of this product has not been approved by the FDA. Biotin should not be used in place of medication prescribed for you by your doctor.

Biotin is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Biotin may also be used for purposes not listed in this product guide.

Pregabalin is used with other medicines to help control partial seizures (convulsions) in the treatment of epilepsy. pregabalin will not cure epilepsy and will only work to control seizures for as long as you continue to take it.

Pregabalin 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).

Pregabalin works in the central nervous system (CNS) to control seizures and pain. It is an anticonvulsant and neuropathic pain agent.

pregabalin is available only with your doctor's prescription.

Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D, especially conditions of the skin or bones.

Cholecalciferol may also be used for purposes not listed in this medication guide.

Name of the medicinal product

Qualitative and quantitative composition

A dibenzoxepin tricyclic compound. It displays a range of pharmacological actions including maintaining adrenergic innervation. Its mechanism of action is not fully understood, but it appears to block reuptake of monoaminergic neurotransmitters into presynaptic terminals. It also possesses anticholinergic activity and modulates antagonism of histamine H(1)- and H(2)-receptors.

Each capsule contains the following inactive ingredients: Mannitol, maize starch and talc.

Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23.

Pregabalin 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.

Vitamin D3 (Vitamin D2) is a derivative of ergosterol formed by ultraviolet rays breaking of the C9-C10 bond. It differs from cholecalciferol in having a double bond between C22 and C23 and a methyl group at C24.

Special warnings and precautions for use

Use Pregabalin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pregabalin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pregabalin refilled.
• Take Pregabalin by mouth with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Taking Pregabalin at the same time each day will help you remember to take it.
• Take Pregabalin on a regular schedule to get the most benefit from it.
• If you miss a dose of Pregabalin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pregabalin.

Biotin is a water soluble B-complex vitamin needed for normal growth and development of skin and hair and maintenance of a healthy nervous system and bone marrow. It is used to prevent and treat biotin deficiency associated with pregnancy, long-term tube feeding, malnutrition, and rapid weight loss. It is also used orally for hair loss, brittle nails, skin rash in infants (seborrheic dermatitis), diabetes, and mild depression.

Fibromyalgia (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

Data from a limited number of patients in a controlled trial suggest that pregabalin 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, pregabalin 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.

Vitamin D3 is used for the prevention and treatment of vitamin D deficiency. Vitamin D3 is important for absorption of calcium in the body. It is also used to prevent bone disorders such as osteomalacia and rickets.

Dosage (Posology) and method of administration

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule,

Meribin: 5 mg

Capsule,

Biotin Extra Strength: 10 mg [gluten free; contains soybean lecithin, soybean oil]

Generic: 5000 mcg

Tablet,

Generic: 1000 mcg, 5 mg, 10 mg

Tablet,

Generic: 300 mcg [DSC], 1000 mcg

Dietary supplementation (OTC labeling):

Dosage: One tablet or capsule daily; also see specific product labeling

Refer to adult dosing.

Biotinidase deficiency, symptomatic: Limited data available: Infants, Children, and Adolescents:

The dose range is 150 to 600 mg per day given in either two or three divided doses.

Epilepsy: Pregabalin 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.

Pregabalin 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 Pregabalin: In accordance with current clinical practice, if pregabalin 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: Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As pregabalin 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.

Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the pregabalin 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 Pregabalin 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 pregabalin due to a decreased renal function.

Administration: Pregabalin may be taken with or without food.

Pregabalin is for oral use only.

1 tab daily.

Interaction with other medicinal products and other forms of interaction

See also:
What other drugs will affect Biotin?

The anticonvulsants carbamazepine, phenytoin, Phenobarbital, and primidone may accelerate biotin metabolism, leading to a reduction in available biotin. Chronic use of these drugs has been associated with decreased plasma concentrations of biotin.

The use of antibiotics may reduce the contribution of biotin made by bacteria within the large intestine.

See also:
What other drugs will affect Pregabalin?

Since Pregabalin 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 Pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between Pregabalin and commonly used antiepileptic drugs.

Multiple oral doses of Pregabalin 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 Pregabalin was co-administered with these drugs. No clinically important effects on respiration were seen.

Pregabalin is a Schedule V controlled substance.

Pregabalin 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 Pregabalin misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior).

In a study of recreational users (N=15) of sedative/hypnotic drugs, including alcohol, Pregabalin (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 Pregabalin-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%.

In clinical studies, following abrupt or rapid discontinuation of Pregabalin, 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.

See also:
What other drugs will affect Vitamin D3?

Interactions for vitamin D analogues (Vitamin D2, Vitamin D3, Calcitriol, and Calcidiol)

Cholestyramine

Cholestyramine has been reported to reduce intestinal absorption of fat soluble vitamins; as such it may impair intestinal absorption of any of vitamin D

Phenytoin/Phenobarbital

The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of vitamin D, but may reduce endogenous plasma levels of calcitriol/ergocalcitriol by accelerating metabolism. Since blood level of calcitriol/ergocalcitriol will be reduced, higher doses of Rocaltrol may be necessary if these drugs are administered simultaneously

Thiazides

Thiazides are known to induce hypercalcemia by the reduction of calcium excretion in urine. Some reports have shown that the concomitant administration of thiazides with vitamin D causes hypercalcemia. Therefore, precaution should be taken when coadministration is necessary

Digitalis

Vitamin D dosage must be determined with care in patients undergoing treatment with digitalis, as hypercalcemia in such patients may precipitate cardiac arrhythmias

Ketoconazole

Ketoconazole may inhibit both synthetic and catabolic enzymes of vitamin D. Reductions in serum endogenous vitamin D concentrations have been observed following the administration of 300 mg/day to 1200 mg/day ketoconazole for a week to healthy men. However, in vivo drug interaction studies of ketoconazole with vitamin D have not been investigated

Corticosteroids

A relationship of functional antagonism exists between vitamin D analogues, which promote calcium absorption, and corticosteroids, which inhibit calcium absorption

Phosphate-Binding Agents

Since vitamin D also has an effect on phosphate transport in the intestine, kidneys and bones, the dosage of phosphate-binding agents must be adjusted in accordance with the serum phosphate concentration

Vitamin D

The coadministration of any of the vitamin D analogues should be avoided as this could create possible additive effects and hypercalcemia

Calcium Supplements

Uncontrolled intake of additional calcium-containing preparations should be avoided

Magnesium

Magnesium-containing preparations (eg, antacids) may cause hypermagnesemia and should therefore not be taken during therapy with vitamin D by patients on chronic renal dialysis.