Кармазин таблетки инструкция по применению

В состав БАДов Карнозин входит одноименное действующее вещество, которое является дипептидом. Карнозин состоит из остатков двух аминокислот — аланина и гистидина. Это мощный антиоксидант, который защищает клетки от разрушения свободными радикалами и повышает их работоспособность. Он замедляет старение и «переключает» клетки на процесс омоложения. За эти свойства Карнозин получил название «эликсира молодости» и геропротектора.

Карнозин: где содержится?

В природе вещество содержится как в пище, так и в организме человека. Больше всего находится карнозина в головном мозге, нейронах и мышцах, в том числе и в миокарде — сердечной мышце.

Препараты с Карнозином выпускают для перорального применения. Стандартная дозировка капсул (таблеток) 500 мг. В аптеках можно приобрести Карнозин следующих производителей:

• Карнозин (таблетки, Квадрат-С)
• Карнозин Эвалар Anti-Age (капсулы, Эвалар)
• Карнозин Tetralab (таблетки, Квадрат-С)
• NOW L-карнозин (капсулы, NOW FOODS)

Обращаем внимание, что в линейке Solgar (популярного производителя БАДов) Карнозин Солгар на российском рынке не представлен.

Карнозин — геропротекторное средство, которое защищает клетки от повреждений и разрушения и замедляет их старение. Что еще делает Карнизон:

• предупреждает структурные изменения коллагена в коже, поддерживает тонус кожи, восстанавливает овал лица и разглаживает мелкие морщины
• борется с окислительными стрессом (действием свободных радикалов) и уменьшает воздействие негативных факторов на организм
• поддерживает работу иммунной и сердечно-сосудистой системы, повышает выносливость сердечной мышцы и восстанавливает эластичность сосудов
• утилизирует гормоны стресса — кортизол и норадреналин
• замедляет возрастные изменения в хрусталике глаза
• повышает выносливость при спортивных тренировках, уменьшает утомляемость, ускоряет восстановление после них

Карнозин и Карнитин: в чем разница?

Карнитин содержит витаминоподобное вещество левокарнитин, Карнозин — дипептид аминокислот аланин и гистидин. Основное действие Карнитина в организме — получение энергии и участие в обмене веществ, Карнозина — антиоксидантное и замедляющее старение клеток.

Перед применением Карнозина рекомендуется проконсультироваться с врачом. Гиперчувствительность к любым компонентам препарата, детский возраст, беременность и период лактации являются противопоказанием к приему Карнозина.

Как правило, средство переносится хорошо, к нему нет привыкания, отсутствует опасность передозировки. Карнозин не накапливается в организме: его избыток подвергается расщеплению ферментом карнозиназой на составляющие аминокислоты, которые легко выводятся из организма.

Японские исследователи первыми создали препарат на основе комплексного соединения карнозина и цинка. Такой хелатный комплекс* обладает выраженным противоязвенным эффектом и уменьшает повреждение слизистой желудка, вызванное различными факторами.

Цинк l Карнозин: вред и польза

Карнозин Цинк (БАД) оказывает следующие действия на желудочно-кишечный тракт:

• защищает клетки тканей желудка от повреждений
• восстанавливает и поддерживает здоровье желудочно-кишечного тракта
• улучшает состояние кишечной микрофлоры
• снижает секрецию соляной кислоты
• увеличивает выработки защитной слизи

Данный комплекс противопоказан при индивидуальной непереносимости компонентов БАД, беременности, кормлении грудью.

*Хелатный комплекс — соединение металла и органической молекулы. Слово «хелат» произошло от греческого «chele» — клешня, так как хелатные соединения похожи на клешни краба, окружающие ион металла. Ионы, находясь в оболочке аминокислоты (хелатного комплекса), не требуют дополнительных превращений в организме и являются готовыми к всасыванию в тонкой кишке. Это повышает их усвояемость и оказываемое на организм действие.

• В состав препарата Карнозин входит одноименное действующее вещество. Это дипептид из остатков двух аминокислот: аланина и гистидина.
• Карнозин является мощным антиоксидантом, «ловушкой» для свободных радикалов. Он защищает клетки от повреждений и замедляет их старение.
• Карнозин почти не имеет побочных действий. БАД противопоказан при индивидуальной непереносимости компонентов, беременности, кормлении грудью, детям.
• Хелатный комплекс цинка и карнозина обладает выраженным противоязвенным эффектом и уменьшает повреждение слизистой желудка.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder

Carmazin is indicated for treatment of patients with acute manic or mixed episodes associated with bipolar I disorder.

Pain Of Trigeminal Neuralgia

Carmazin is indicated in the treatment of the pain associated with trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.

Epilepsy

Carmazin is indicated for the treatment of partial seizures with complex symptomatology (e.g., psychomotor, temporal lobe), generalized tonic-clonic seizures (grand mal), and mixed seizure patterns, which include the seizure types listed here or other partial or generalized seizures..

Limitations Of Usage

Carmazin is not indicated for the treatment of absence seizures (petit mal).Carmazin has been associated with increased frequency of generalized convulsions in these patients.

DOSAGE AND ADMINISTRATION

Pretreatment Screening

Prior to initiating treatment with Carmazin, test patients with ancestry in genetically at-risk populations for the presence of the HLA-B*1502 allele. The high resolution genotype test is positive if one or two HLA-B*1502 alleles are present. Avoid use of Carmazin in patients testing positive for the allele, unless the benefit clearly outweighs the risk.

Complete pretreatment blood counts, including platelets and possibly reticulocytes and serum iron, should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of Carmazin should be considered if any evidence of significant bone marrow depression develops.

Baseline and periodic evaluations of liver function, particularly in patients with a history of liver disease, must be performed during treatment with Carmazin because liver damage may occur. Discontinue Carmazin in cases of aggravated liver dysfunction or active liver disease.

Baseline and periodic eye examinations, including slit-lamp, funduscopy, and tonometry, are recommended since many phenothiazines and related drugs have been shown to cause eye changes.

Baseline and periodic complete urinalysis and BUN determinations are recommended for patients treated with this agent because of observed renal dysfunction.

Dosage For Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder

The recommended initial dose of Carmazin is 200 mg administered twice daily. The dose may be increased by 200 mg per day to achieve optimal clinical response. Doses higher than 1600 mg per day have not been studied in mania associated with bipolar disorder.

Dosage For Pain Of Trigeminal Neuralgia

Initial: On the first day, start with one 200 mg capsule once daily. This dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours only as needed to reach an effective and tolerated dose. Do not exceed a total daily dose of 1200 mg.

Maintenance: Control of pain can be maintained in most patients with 400 mg to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.

Dosage For Epilepsy

Adults And Children Over 12 Years Of Age

The recommended initial dose is 200 mg administered twice daily. Increase in weekly increments of 200 mg a day, administered as an equally divided, twice daily dose, until an optimal response is obtained. Dosage generally should not exceed 500 mg twice daily in children 12 to 15 years old; 600 mg twice daily in children 15 to 18 years old; and 800 mg twice daily in adults.

Children Under 12 Years Of Age

Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. No recommendation regarding the safety of Carmazin for use at doses above 35 mg/kg/24 hours can be made.

Co-Administration With Other AEDs

Carmazin may be used alone or with other AEDs. When added to existing AEDs, add Carmazin gradually while the dosage(s) of other AEDs are maintained or gradually decreased. Potential drug interactions should be considered when using Carmazin with other AEDs.

Switching From Immediate-Release Carmazin To Carmazin

Carmazin is an extended-release formulation for twice a day administration. When converting patients from immediate release Carmazin to Carmazin extended-release capsules, the same total daily mg dose of Carmazin should be administered. Following conversion to Carmazin, patients should be closely monitored for seizure control. Depending on the therapeutic response after conversion, the total daily dose may need to be adjusted within the recommended dosing instructions.

Discontinuation Of Carmazin

When discontinuing Carmazin used for any indication, reduce the dose gradually and avoid abrupt discontinuation in order to decrease the risk of seizure.

Monitoring Serum Carmazin Concentration

Monitoring serum Carmazin concentrations may be useful for dose selection, minimizing toxicity, and verifying drug compliance, especially in clinical conditions in which alterations in Carmazin metabolism can occur (e.g., drug interactions). In pediatric patients treated with Carmazin for epilepsy, if satisfactory clinical response has not been achieved, measure plasma levels to determine whether or not they are in the therapeutic range.

Administration Instructions

Swallow Carmazin capsules whole or open and sprinkle the beads over food, such as a teaspoon of applesauce. Do not crush or chew Carmazin capsules or the beads inside the capsule. Carmazin can be taken with or without meals.

Carmazin is used to treat certain types of seizures (epilepsy). It is also used to relieve pain due to trigeminal neuralgia (tic douloureux) and in the treatment of bipolar disorder (manic-depressive illness). Carmazin works in the brain and nervous system to control seizures, pain, and bipolar disorder. Carmazin is an anticonvulsant.

Carmazin is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Carmazin is used in certain patients with the following medical conditions:

• Alcohol withdrawal.
• Bipolar disorder (manic-depressive illness), prevention.
• Central partial diabetes insipidus (water diabetes).
• Neurogenic pain (a type of continuing pain).
• Psychotic disorders (severe mental illness).

Dosage Information

Carmazin is a replacement therapy for oral Carmazin. Carmazin treatment should generally be initiated with an oral Carmazin formulation.

The total daily dose of Carmazin is 70% of the total daily oral Carmazin dose from which patients are being switched. The total daily dose of Carmazin should be equally divided in four 30-minute infusions, separated by 6 hours.

Patients should be switched back to oral Carmazin administration at their previous total daily oral dose and frequency of administration as soon as clinically appropriate. The use of Carmazin for periods of more than 7 days has not been studied.

Table 1. Determination of Total Daily Dose for Carmazin Infusion

Administration Information

Carmazin is for intravenous use only and must be diluted in a compatible diluent prior to infusion.

Using Table 2 as a guide, prepare the solution for each infusion by transferring the single dose volume of Carmazin to 100 mL of diluent solution (0.9% sodium chloride, lactated Ringer’s solution, or 5% dextrose) and mixing gently.

Before administration, the prepared solution for infusion may be stored for a maximum of 4 hours at 20°C to 25°C (68°F to 77°F) or a maximum of 24 hours if refrigerated at 2°C to 8°C (36°F to 46°F).

Parenteral drug products should be inspected visually for particulate matter, cloudiness, or discoloration prior to administration, whenever solution and container permit. If any of these are present, discard the solution.

Administer each infusion intravenously over 30 minutes.

Carmazin injection vials are for single-dose only. Discard any unused portion.

Table 2. Carmazin Dose to Volume and Infusion Table

Renal Function Monitoring

Patients with renal impairment may be at greater risk for an adverse effect of Carmazin on renal function, and should have close monitoring of renal function during treatment with Carmazin. Carmazin should generally not be used in patients with moderate or severe renal impairment.

Serum Level Monitoring

Monitor serum Carmazin concentrations in conditions in which alterations in Carmazin metabolism can occur. This includes patients who have hepatic impairment and patients on drugs that either induce or inhibit Carmazin metabolism.

Laboratory Testing Prior To Carmazin Initiation

Prior to initial treatment with Carmazin, test patients with ancestry in genetically at-risk populations for the presence of the HLA-B*1502 allele. The high resolution genotype test is positive if one or two HLA-B*1502 alleles are present. Avoid use of Carmazin in patients testing positive for the allele, unless the benefit clearly outweighs the risk.

Complete pretreatment blood counts, including platelets and possibly reticulocytes and serum iron, should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of Carmazin should be considered if any evidence of significant bone marrow depression develops.

Baseline and periodic evaluations of liver function, particularly in patients with a history of liver disease, must be performed during treatment with Carmazin because liver damage may occur. Discontinue Carmazin in cases of aggravated liver dysfunction or active liver disease.

How supplied

Dosage Forms And Strengths

Carmazin injection contains 200 mg/20 mL (10 mg/mL) Carmazin as a clear, colorless, sterile solution in a single-dose vial.

Storage And Handling

Carmazin (Carmazin) 200 mg/20 mL (10 mg/mL) injection is a clear, colorless, sterile solution. It is supplied in single-dose 20 mL glass vials, available in cartons of one vial (NDC 67386-621-52). Not made with natural rubber latex.

Storage And Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Manufactured by: Baxter Pharmaceuticals Solutions, LLC, Bloomington, IN 47403, U.S.A. Revised: October 2016

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

You should not take Carmazin if you have a history of bone marrow suppression, if you are also taking nefazodone, or if you are allergic to an antidepressant such as amitriptyline, desipramine, imipramine, or nortriptyline.

This medication may cause severe or life-threatening skin rash. Your doctor may recommend a blood test before you start the medication to determine your risk.

Do not start or stop taking Carmazin during pregnancy without your doctor’s advice. Carmazin may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant while taking Carmazin for seizures.

TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE. Some drugs can raise or lower your blood levels of Carmazin, which may cause side effects or make Carmazin less effective. Carmazin can also affect blood levels of certain other drugs, making them less effective or increasing side effects.

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

• Carmazin suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Carmazin suspension refilled.
• Take Carmazin suspension by mouth with food.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you also take other liquid medicines or products, especially chlorpromazine or thioridazine liquids, do not take them at the same time you take Carmazin suspension. Ask your doctor how you should take them with Carmazin suspension.
• Eating grapefruit or drinking grapefruit juice may increase the risk of Carmazin suspension’s side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• Do not suddenly stop taking Carmazin suspension. You may have an increased risk of seizures. If you need to stop Carmazin suspension, your doctor will gradually lower your dose.
• Taking Carmazin suspension at the same time each day will help you remember to take it.
• Take Carmazin suspension on a regular schedule to get the most benefit from it.
• Continue to take Carmazin suspension even if you feel well. Do not miss any doses.
• If you miss a dose of Carmazin suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 Carmazin suspension.

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.

Carmazin is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia). This medication works by reducing the spread of seizure activity in the brain and restoring the normal balance of nerve activity.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat certain mental/mood conditions (such as bipolar disorder) and other types of nerve pain.

How to use Carmazin

Read the Medication Guide provided by your pharmacist before you start using Carmazin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

If you are taking the extended-release tablets, take this medication by mouth with food as directed by your doctor, usually 2 times a day. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Inspect the tablets for chips and cracks. Do not take any damaged tablets.

If you are taking the extended-release capsules, take this medication by mouth with or without food as directed by your doctor, usually 2 times a day. Swallow the capsules whole. Do not crush or chew the capsules.

If you have trouble swallowing the capsules, you may open them and sprinkle the contents onto a teaspoonful of applesauce or other soft food. Swallow all of the drug/food mixture right away. Do not chew the mixture or prepare a supply in advance.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It is important to continue taking this medication even if you feel well.

Do not stop taking this medication without consulting your doctor. Some conditions (such as seizures) may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition does not improve or if it worsens.

See also:
What other drugs will affect Carmazin?

Clinically meaningful drug interactions have occurred with concomitant medications and include, but are not limited to the following:

Agents Highly Bound to Plasma Protein

Carmazin is not highly bound to plasma proteins; therefore, administration of Carmazin® (Carmazin extended-release) to a patient taking another drug that is highly protein bound should not cause increased free concentrations of the other drug.

Agents that Inhibits Cytochrome P450 Isoenzymes and/or Epoxide Hydrolase

Carmazin is metabolized mainly by cytochrome P450 (CYP) 3A4 to the active Carmazin 10,11-epoxide, which is further metabolized to the trans-diol by epoxide hydrolase. Therefore, the potential exists for interaction between Carmazin and any agent that inhibits CYP3A4 and/or epoxide hydrolase. Agents that are CYP3A4 inhibitors that have been found, or are expected, to increase plasma levels of Carmazin® (Carmazin extended-release) are the following:

Acetazolamide, azole antifungals, cimetidine, clarithromycin(1), dalfopristin, danazol, delavirdine, diltiazem, erythromycin(Phenytoin has also been reported to decrease in the presence of Carmazin. Careful monitoring of phenytoin plasma levels following co-medication with Carmazin is advised.

Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of the treatment with Carmazin® (Carmazin extended-release), it is reasonable to expect that a dose decrease for the concomitant agent may be necessary.

Pharmacological/Pharmacodynamic Interactions with Carmazin

Concomitant administration of Carmazin and lithium may increase the risk of neurotoxic side effects.

Given the anticonvulsant properties of Carmazin, Carmazin® (Carmazin extended-release) may reduce the thyroid function as has been reported with other anticonvulsants. Additionally, anti-malarial drugs, such as chloroquine and mefloquine, may antagonize the activity of Carmazin.

Thus if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with Carmazin® (Carmazin extended-release), it is reasonable to expect that a dose adjustment may be necessary.

Because of its primary CNS effect, caution should be used when Carmazin (Carmazin extended-release) ® is taken with other centrally acting drugs and alcohol.

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

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

• Serious Dermatologic Reactions: Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome
• Aplastic anemia/agranulocytosis
• Drug Reaction with Eosinophilia and Systemic Symptoms/Multiorgan Hypersensitivity
• Suicidal Behavior and Ideation
• Embryofetal Toxicity
• Abrupt Discontinuation and Seizure Risk
• Hyponatremia
• Cognitive and Motor Impairment
• Drug Interaction with Non-Nucleoside Reverse Transcriptase Inhibitors
• Liver Damage
• AV Heart Block
• Hepatic Porphyria
• Increased Intraocular Pressure

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most commonly reported adverse reactions (>5% in the Carmazin group and at least twice placebo) in the pooled 3-week placebo-controlled trials in patients with acute mania associated with Bipolar I Disorder (Studies 1 and 2) were dizziness, somnolence, nausea, vomiting, ataxia, constipation, pruritus, dry mouth, asthenia, blurred vision, and speech disorder. The Carmazin doses used were 400 to 1600 mg per day.

Table 2. Common Adverse Reactions Reported in Bipolar Disorder Studies 1 and 2 (Incidence > 2% and greater than placebo)

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Carmazin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous System: confusion, diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, tinnitus.

Digestive System: gastric distress, abdominal pain, diarrhea, anorexia.

Laboratory Tests: thyroid function tests (T3, T4)- decreased values

Other: lupus erythematosus-like syndrome

One case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking Carmazin in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with Carmazin.

Additional Adverse Reactions Associated With Carmazin

The following is a list of additional adverse reactions identified in clinical trials or postmarketing reports of other forms of Carmazin and not reported above for Carmazin. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Nervous System: Isolated cases of neuroleptic malignant syndrome have been reported in Carmazin use both with and without concomitant use of other psychotropic drugs.

Skin: onychomadesis, acute generalized exanthematous pustulosis (AGEP).

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-8669VALIDUS(1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Carmazin is 5H-dibenzo[b,f]azepine-5-carboxamide.

Excipients/Inactive Ingredients: Tablet: Aerosil 200 (silica, colloidal anhydrous), Avicel PH 101 (cellulose) magnesium stearate, Nymcel ZSB-10 modified (carmellose sodium, low substituted).

CR Tablet: Aerosil 200 (silica, colloidal anhydrous), ethylcellulose aqueous dispersion, Avicel PH 102 (cellulose), Eudragit ED solid (copolymer based on polyacrylic/methacrylic esters), magnesium stearate, sodium CMC XL, talc. Coating: Cellulose-HP-M 603 (hydroxypropyl methylcellulose), Cremophor RH 40 (glyceryl polyoxyethylene glycol stearate), iron oxide red, iron oxide yellow, talc, titanium dioxide.

Oral Suspension:

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