tamoxifen alternatives

Below is a list of adverse reactions that are in controlled clinical trials were recorded in children under 2 or tamoxifen alternatives more times more frequently than in adults: loss of appetite, increased appetite, hyperchloraemic acidosis, hypokalemia, behavioral disorders, aggressive reaction, apathy, disturbance of sleep, suicidal thoughts , impaired concentration, lethargy, circadian rhythm sleep, poor quality sleep, lacrimation increased, sinus bradycardia, feeling unwell, gait disturbance.

Below is a list of adverse reactions that are in controlled clinical trials were registered only in children: eosinophilia, psychomotor hyperactivity, vertigo, vomiting, hyperthermia, pyrexia, impaired ability to learn.

Overdose

Signs and symptoms of an overdose of the drug tamoxifen alternatives: convulsions, drowsiness, speech disturbances, and vision, diplopia, impaired judgment, impaired coordination, lethargy, stupor, hypotension, abdominal pain, dizziness, agitation and depression. In most cases, clinical consequences were not severe, but were observed after an overdose deaths, using a mixture of several drugs, including topiramate. Overdose topiramate can cause severe the metabolic acidosis-cue (see. “Special Instructions” section).

A case of overdose when the patient has received a dose of topiramate is from 96 to 110 g, which resulted in a coma, which lasted 20-24 hours. After 3-4 days of overdose symptoms resolved.

Treatment

In acute overdose of the drug tamoxifen alternatives , if shortly before the patient took food, should immediately wash out the stomach and cause vomiting. In in vitro studies have shown that activated carbon adsorbs topiramate. If necessary spend symptomatic therapy. An effective way of removing topiramate from the body is hemodialysis. Patients are advised to increase the volume of adequate fluid intake.

Interaction with other drugs

Effect at concentrations of other antiepileptic drugs 

Simultaneous treatment) has no effect on the values of their equilibrium concentrations in the plasma, except for certain patients in whom the addition to phenytoin may increase phenytoin concentrations plasma. This may be due to inhibition of a specific enzyme polymorphic isoform of cytochrome . Therefore, each patient who receives phenytoin and which develop clinical signs or symptoms of toxicity, it is necessary to monitor the concentration of phenytoin in plasma. In a study of the pharmacokinetics in patients with epilepsy the addition of topiramate to lamotrigine had no effect on the equilibrium concentration of the last at doses of 100-400 mg topiramate per day. During and after the abolition of lamotrigine (mean dose of 327 mg per day), the equilibrium concentration of topiramate did not change.

Effects of other antiepileptic drugs on the concentration of the drug 

Phenytoin and carbamazepine concentrations reduce the drug lasma. The addition or withdrawal of phenytoin or carbamazepine on the background of treatment  may require a change in the dose of the latter. The dose should be selected, focusing on achieving the desired clinical effect. The addition or withdrawal of valproic acid does not cause clinically significant changes in the concentration of the drug tamoxifen alternatives in plasma and, hence, enforcement does not require changes .

Digoxin: a study with a single dose of the area under the curve “concentration-time” of digoxin in plasma while taking  was decreased by 12%. The clinical relevance of this observation is not clear. The appointment or termination patients receiving digoxin, special attention should be paid to monitoring of digoxin serum concentrations.

Means, depressing the central nervous system: in clinical studies the effects of co-administration with alcohol or other substances depressing the central nervous system, have not been studied. It is recommended  with alcohol or other drugs that cause central nervous system depression.

St. John’s wort
a joint reception Topamax and on the basis of Hypericum perforatum preparations (Hypericum perforatum) the concentration of topiramate in plasma can be reduced and, as a consequence, the effectiveness of the drug may also decrease. Clinical studies of the interaction of the drug tamoxifen alternatives® and preparations based on St. John’s wort is not held.

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tamoxifen for men

Psychiatric disorders: very common: tamoxifen for men depression; often: slow thinking, insomnia, violations of free speech, anxiety, confusion, disorientation, aggressive reactions, mood disorders, agitation, emotional lability, depressed mood, anger, behavioral disorders; rare: suicidal ideation, suicide attempt, hallucination, psychotic disorder, auditory hallucinations, visual hallucinations, lethargy, slurred speech, sleep disorders, affective lability, decreased libido, restlessness, crying, disfemiya, euphoric mood, paranoia, perseveration of thought, panic attacks , tearfulness, reading skills violation, violation of sleep, flattening of emotions, thinking abnormal, loss of libido, fatigue, intrasomnicheskoe disorder, distraction, early morning awakening, panic reaction, elevated mood; Rare: mania, panic disorder, feeling of despair *, hypomania.

Disorders of the central nervous system: very common: paraesthesia, somnolence, dizziness; often: impaired concentration, memory impairment, amnesia, cognitive disorders, abnormal thinking, psychomotor disturbances, convulsions, loss of coordination of movements, tremor, confusion, hypesthesia, nystagmus, dysgeusia, disturbance of sense of balance, dysarthria, intention tremor, sedation;rare: depression of consciousness, tonic-clonic seizures tamoxifen for men by type of «grand mal», infringement of sight, complex partial seizures, speech disorder, psychomotor hyperactivity, syncope, sensory disturbance, drooling, hypersomnia, aphasia, repetitive speech, hypokinesia, dyskinesia, postural dizziness poor quality sleep, burning sensation, numbness, parosmiya, cerebral syndrome, dysesthesia, gipogevziya, stupor, clumsiness, aura, ageusia, dysgraphia, dysphasia, peripheral neuropathy, presyncope, dystonia, a feeling of “chills” through the body; rare: apraxia, circadian rhythm sleep, hypersensitivity, hyposphresia, anosmia, essential tremor, akinesia, lack of response to stimuli.

Violations of the organ of vision: common: blurred vision, diplopia, blurred vision; rare: decrease in visual acuity, scotoma, myopia *, strange sensations in the eyes *, dry eye, photophobia, blepharospasm, increased lacrimation, photopsia, mydriasis, presbyopia; rare: blindness unilateral, blindness transient, glaucoma, accommodation disturbance, disturbance of the visual spatial perception, scintillating scotoma, eyelid edema *, night blindness, amblyopia; Frequency unknown: angle-closure glaucoma *, maculopathy *, eye motility disorders *.

Violations of the organ of hearing and balance: common: vertigo, ringing in the ears, ear pain; Uncommon: tamoxifen for men deafness, unilateral hearing loss, sensorineural deafness, discomfort in the ear, hearing loss.

Violations of the cardiovascular system: rare: bradycardia, sinus bradycardia, palpitations.

Violations of the circulatory system: rare: hypotension, orthostatic hypotension, flushing, hot flashes; rare: Raynaud’s phenomenon.

Disorders of the respiratory system, organs, thoracic and mediastinal disorders: common: dyspnea, epistaxis, nasal congestion, rhinorrhea, cough *; uncommon: shortness of breath on exertion, hypersecretion in the sinuses, dysphonia.

Disorders of the gastrointestinal tract: Very common: nausea, diarrhea; common: vomiting, constipation, upper abdominal pain, dyspepsia, abdominal pain, dry mouth, stomach discomfort, disturbance of sensation in the mouth, gastritis, abdominal discomfort; uncommon: pancreatitis, flatulence, gastroesophageal reflux, pain in the lower abdomen, reduced sensitivity in the mouth, bleeding gums, bloating, discomfort in the epigastric region, the sensitivity of the abdomen, hypersalivation, pain in the mouth, bad breath, glossodiniya .

Violations of the hepatobiliary system: rare: hepatitis, liver failure.

Disorders of the skin and subcutaneous tissue disorders: common: alopecia, rash, itching; rare: anhidrosis, the sensitivity of the violation in the area of the face, urticaria, erythema, pruritus generalized, rash macular, violation of skin pigmentation, allergic dermatitis, swelling of the face; rare: Stivenca-Johnson Syndrome, erythema multiforme *, skin odor, periorbital edema *, urticaria localized; Frequency not known: toxic epidermal necrolysis *.

Violations of the musculoskeletal system and connective tissue disorders: common: arthralgia, muscle cramps, myalgia, muscle cramps, muscle weakness, musculoskeletal chest pain; Uncommon: joint swelling * muscle stiffness, flank pain, muscle fatigue; rare: * discomfort in the limbs.

Violations of the kidney and urinary tract: common: nephrolithiasis, pollakiuria, dysuria; rare: exacerbation of urolithiasis (kidney stones), stress incontinence, hematuria, urinary incontinence, frequent urination, renal colic, pain in the kidneys; rare: exacerbation of urolithiasis (stones in the urethra) * pochechnokanaltsevy acidosis.

Violations of the genital organs and the breast: Uncommon: erectile dysfunction, sexual dysfunction.

General disorders and disorders caused by the use of the method: very common: fatigue; common: fever, asthenia, stimulus-ness, gait disturbance, malaise, anxiety; rare: Hyperthermia, thirst, influenza-like syndrome *, sluggishness, cold extremities, feeling drunk, feeling of anxiety; Rare: facial edema, calcification. Changes in laboratory parameters: very common: weight loss; common: weight gain *; rare: crystalluria, an abnormal test result “tandem gait”, leukopenia, increased serum liver enzymes, rare: decrease in the content of hydrocarbons in the blood.

Disorders  tamoxifen for menof social functioning: rare: impaired ability to learn.

* – Adverse reaction recorded in the post-registration period from spontaneous reports. The frequency is calculated based on clinical trial data.

 

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tamoxifin

At the beginning of the treatment the patient should take 25 mg of the drug tamoxifin at bedtime for 1 week. Then the dose is increased at intervals of 1 – 2 weeks at 25 or 50 mg (daily dose is divided into two steps). If the patient can not tolerate a dose escalation mode, it is possible to increase the intervals between increasing dose or increase the dose more slowly. In the selection of dose should be guided by clinical effect. The initial dose of topiramate monotherapy in adults is 100 mg per day and the maximum daily dose should not exceed 500 mg. Some patients with refractory forms of epilepsy tolerate topiramate monotherapy at doses up to 1000 mg per day. These dosing recommendations apply to all adults, including elderly patients without renal disease.

Monotherapy: children

Children under 2 years of age in the first week of treatment should be given topiramate at a dose of 0.5-1 mg / kg body weight before bedtime. The dose was then increased at intervals of 1-2 weeks at 0.5-1 mg / kg per day (daily dose is divided into two steps). If a child can not tolerate such a dose escalation mode, it is possible to increase the dose more gradually or increase the interval between increasing the dose. The size of the dose and the speed of its increase should be determined by clinical outcome.
The recommended dose range of topiramate monotherapy in children over the age of 2 years is 100-400 mg / day. Children with newly diagnosed partial seizures can be assigned up to 500 mg per day.

Migraine

The recommended total daily dose of topiramate for prophylaxis of migraine is 100 mg, taken in 2 divided doses. At the beginning of the treatment the patient should take 25 mg of the drugtamoxifinat bedtime for 1 week. Thereafter, the dosage is increased at intervals of 1 week to 25 mg per day. If the patient can not tolerate such a regime of increasing doses, then you can increase the interval between increases in the dose or increase the dose more slowly. In the selection of dose should be guided by clinical effect.

In some patients, a positive result is obtained at a daily dose of 50 mg topiramate. In clinical studies, patients received different daily doses of topiramate, but not more than 200 mg per day.

Special patient groups

 

  1. Renal Insufficiency
    Patients with moderate or severe renal impairment may require dose reduction.It is recommended to use half the recommended initial and maintenance dose.
  2. Hemodialysis
    Since topiramate is tamoxifin removed from plasma by hemodialysis, in the days of hemodialysis should be given an additional  , equal to about half of the daily dose.An extra dose should be divided into two doses taken at the beginning and after the end of hemodialysis.Additional dose may vary depending upon the characteristics of the equipment used to perform hemodialysis.
  3. Hepatic impairment
    Patients with hepatic impairment topiramate should be used with caution.

The most common adverse reactions (frequency of which was greater than 5% and greater than that in the placebo group, at least one of the indications in the controlled clinical trials of topiramate) include: anorexia, decreased appetite, slow thinking, depression, violations of free speech, insomnia, disorders motor coordination, impaired concentration, dizziness, dysarthria, dysgeusia, hypoesthesia, lethargy, memory impairment, nystagmus, paresthesia, somnolence, tremor, diplopia, blurred vision, diarrhea, nausea, fatigue, irritability and a decrease in body weight.

Infections and infestations: Very common: nasopharyngitis *.

Violations of the blood and lymphatic system: common: anemia; rare: leucopenia, lymphadenopathy, thrombocytopenia, eosinophilia; rare: neutropenia *.

Violations of the immune system: common tamoxifin: hypersensitivity; Frequency not known: Allergic edema *, conjunctival edema *.

Violations of the metabolism and nutrition: Common: anorexia, decreased appetite; rare: metabolic acidosis, hypokalemia, increased appetite, polydipsia; rare: hyperchloraemic acidosis.

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what is tamoxifen

In the study in animals found no effect of topiramate on fertility. The effect of topiramate against fertility in humans is not installed. In renal and liver failure, nefrourolitiaze  what is tamoxifen(including past and family history), hypercalciuria.

Dosing and Administration

Inside, regardless of meals. it is recommended to start treatment with low-dose formulation followed by a gradual titration to an effective dose to achieve optimal control of epileptic seizures in children and adults.

The capsules are designed for patients who have difficulty swallowing tablets (for example, children and elderly patients).

Capsules should be carefully opened, mix the contents of the capsules with a small amount (about 1 teaspoon) of a soft food. This mixture should be swallowed immediately without chewing. Do not store the medication, mixed with the food until the next reception.

Capsules what is tamoxifen can be swallowed whole.

Use in combination with other anticonvulsants in adult patients

The minimum effective dose is 200 mg per day. Typically, the total daily dosage is from 200 mg to 400 mg, and is received in two steps. Some patients may need to increase the daily dose to the maximum – 1600 mg. It is recommended to begin treatment with a low dose with a gradual selection of effective dose. Selection of doses begin with 25-50 mg, taking them at night for 1 week. Subsequently, at weekly or biweekly intervals can be increased at a dose of 25-50 mg and take it into two steps. In the selection of dose should be guided by clinical effect. In some patients, the effect can be achieved by taking the drug one time per day. To achieve the optimal effect of treatment with what is tamoxifenis not necessarily monitor its concentration in plasma.
The recommendations for dose apply to all adult patients, including the elderly, in the absence of their kidney disease .

Combined anticonvulsant therapy in children older than 2 years

The recommended total daily dose of the as adjunctive therapy agent is from 5 to 9 mg / kg and is received in two steps. Titration should begin with 25 mg (or less based on the initial dose of 1 to 3 mg / kg per day), taking them at night for one week. Subsequently, at weekly or biweekly intervals dose can be increased to 1 – 3 mg / kg and to take it into two steps. In the selection of dose should be guided by clinical effect. The daily dose of 30 mg / kg is generally well tolerated.

Epilepsy (including newly diagnosed)

Monotherapy: general provisions

If you cancel the related anticonvulsants topiramate monotherapy for the purpose it is necessary to take into account the possible impact of this step on the frequency of seizures. In cases where there is no need to sharply cancel accompanying anticonvulsants for security reasons, it is recommended to reduce their dose gradually reducing the dose of concomitant antiepileptic drugs by what is tamoxifen one-third every 2 weeks.
If you cancel the drugs that are inducers of microsomal liver enzymes, will increase topiramate concentration in the blood . In such situations, if clinically indicated drug dose Topamax ® can be reduced.

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tamoxifen side effects

As monotherapy adults and children older tamoxifen side effects than 2 years of age with epilepsy (including in patients with newly-diagnostic Rowan epilepsy). In the combined therapy: adults and children older than 2 years with partial or generalized tonic-clonic seizures and for the treatment of seizures in the background of Lennox-Gastaut syndrome.

Migraine

Prevention of migraine in adults. The use of the drug Topamax ® has not been studied for the treatment of acute migraine attacks.

Contraindications

Hypersensitivity to any component of this medication, children up to 2 years.

The use of topiramate for migraine prophylaxis is contraindicated during pregnancy and in women with childbearing potential stored not using reliable methods of contraception.

Pregnancy and lactation

Topiramate showed teratogenic properties in mice, rats and rabbits. In rats, topiramate crosses the placental barrier.

Special-controlled studies in which tamoxifen side effectsbe used for the treatment of pregnant women have been conducted. Topiramate may cause harm to the fetus when used in pregnant women. These accounting pregnancies indicate that infants exposed to topiramate in utero during the first trimester of pregnancy have an increased risk of congenital malformations (eg, craniofacial defects, such as cleft lip or palate, hypospadias, and anomalies of the various body systems). These malformations were recorded as the topiramate monotherapy or when used as part of polytherapy.

Data from one of the registers of pregnancies have shown that topiramate monotherapy incidence of major congenital malformations is increased approximately 3-fold compared with the comparison group, not to take anti-epileptic drugs.

Furthermore, it is shown that the risk of teratogenic effects associated with the reception of antiepileptic drugs in the above case of combined therapy, than in the case of monotherapy.

Compared with patients not taking antiepileptic drugs, accounting data of pregnancy in monotherapy  show an increase in the likelihood of low birth weight (less than 2500 g). One of the registers pregnancies showed an increase in the relative number of babies aborted for their gestational  among infants exposed to topiramate in utero. Long-term effects are not defined tamoxifen side effects. The reason for reducing the body weight has not been established at birth .

During therapy with topiramate woman saved childbearing potential must use reliable methods of contraception.

The use of the drug Topamax ® during pregnancy in women with uncontrolled epilepsy is justified only in cases where the potential benefits of the drug to the mother outweighs the potential risk to the fetus.The use of topiramate for migraine prophylaxis is contraindicated during pregnancy and in women with childbearing potential stored not using reliable methods of contraception. In the treatment and counseling of women with childbearing potential, the attending physician must weigh the risk and benefit ratio of treatment and consider alternative treatment options. If tamoxifen side effectsis used during pregnancy, or if the patient becomes pregnant while taking this drug, it should be warned about the potential risk to the fetus.

A limited number of observations of patients suggests that topiramate is excreted in breast milk in women, so the doctor has to take a decision on the refusal from breastfeeding or stopping treatment.

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