DRUGS & SUPPLEMENTS
Makatussin Tropfen Forte
Makatussin Tropfen Forte usesMakatussin Tropfen Forte consists of Dihydrocodeine Hydrochloride, Drosera.
Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets are supplied in tablet form for oral administration.
Each tablet contains:
Dihydrocodeine* bitartrateִִִִִִִִִִִִִִִִִִִִִִ32 mg
*Warning: May be habit forming
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder, is a central nervous system stimulant. It has the following structural formula:
Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmorphinan-6a-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula:
In addition, each tablet also contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.
Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets contain Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) which is a semisynthetic narcotic analgesic related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth muscle components. The principal action of therapeutic value is analgesia.
This combination product also contains acetaminophen, a non-opiate, non-salicylate analgesic and antipyretic. This combination product contains caffeine as an analgesic adjuvant. Caffeine is also a central nervous system and cardiovascular stimulant.
INDICATIONS AND USAGE:
Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets are indicated for the relief of moderate to moderately severe pain.
This combination product is contraindicated in persons with hypersensitivity to Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride), codeine, acetaminophen, caffeine, or any of the inactive components listed above, or any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus.
Usage in Ambulatory Patients:
Makatussin Tropfen Forte may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Respiratory depression is the most dangerous acute reaction produced by opioid agonist preparations, although it is rarely severe with usual doses. Opioids decrease the respiratory rate, tidal volume, minute ventilation, and sensitivity to carbon dioxide. Respiratory depression occurs most frequently in elderly or debilitated patients, usually after large initial doses in nontolerant patients, or when opioids are given in conjunction with other agents that depress respiration. This combination product should be used with caution in patients with significant chronic obstructive pulmonary disease or corpulmonale and in patients with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or respiratory depression. In such patients, alternative non-opioid analgesics should be considered, and opioids should be admin- istered only under careful medical supervision at the lowest effective dose.
This combination product should be used cautiously in the presence of head injury or increased intracranial pressure. The effects of opioids on pupillary response and consciousness may obscure neurologic signs of increases in intracranial pressure in patients with head injuries. The respiratory depressant effects including carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions, or other causes of increased intracranial pressures.
Makatussin Tropfen Forte, like all opioid analgesics, may cause hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted blood volume or who receive concurrent therapy with drugs such as phenothiazines or other agents which compromise vasomotor tone.
Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets may produce orthostatic hypotension in ambulatory patients. This combination product should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.
Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) can produce drug dependence of the codeine type and has the potential of being abused (See DRUG ABUSE AND DEPENDENCE ).
Selection of patients for treatment with Acetaminophen, caffeine, and Makatussin Tropfen Forte bitartrate tablets should be governed by the same principles that apply to the use of similar opioid/non-opioid fixed combination analgesics. As with any such opioid analgesic, the dosing regimen should be adjusted for each patient (see DOSAGE AND ADMINISTRATION ). This combination product should be used with caution in elderly or debilitated patients or those with any of the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); asthma; central nervous system depression or coma; chronic obstructive pulmonary disease; decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis); delirium tremens; head injury; hypotension; increased intracranial pressure; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis. The benefits and risks of using opioids in patients taking monoamine oxidase inhibitors and in those with a history of drug abuse should be carefully considered. The administration of an analgesic containing an opioid may obscure the diagnosis or clinical course in patients with acute abdominal conditions. This combination product may aggravate convulsions in patients with convulsive disorders and, like all opioids, may induce or aggravate seizures in some clinical settings. Acetaminophen is relatively non-toxic at therapeutic doses, but should be used with caution in patients with severe renal or hepatic disease. Care should be observed when using large doses of acetaminophen in malnourished patients or those with a history of chronic alcohol abuse because they may be more susceptible to hepatic damage similar to that observed with toxic overdosage.
Caffeine in high doses may produce central nervous system and cardiovascular stimulation and gastrointestinal irritation.
Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) with Other Central Nervous System Depressants:
Patients receiving other opioid analgesics, sedatives or hypnotics, muscle relaxants, general anesthetics, centrally acting anti-emetics, phenothiazines or other tranquilizers, or alcohol concomitantly with this combination product may exhibit additive depressant effects on the central nervous system. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) with Monoamine Oxidase Inhibitors:
Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride), like all opioid analgesics, interacts with monoamine oxidase inhibitors causing central nervous system excitation and hypertension.
Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) with Mixed Agonist/Antagonist Opioid Analgesics:
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) may reduce the analgesic effect of this combination product.
Chronic and excessive consumption of alcohol may increase the hepatotoxic risk of acetaminophen. The potential for hepatotoxicity with acetaminophen also may be increased in patients receiving anticonvulsants that induce hepatic microsomal enzymes (including phenytoin, barbiturates, and carbamazepine) or isoniazide. Chronic ingestion of large doses of acetaminophen may slightly potentiate the effects of warfarin- and indandione- derivative anticoagulants. Severe hypothermia is possible in patients receiving acetaminophen concomitantly with phenothiazines.
Caffeine may enhance the cardiac inotropic effects of beta-adrenergic stimulating agents. Coadministration of caffeine and disulfiram may lead to a substantial decrease in caffeine clearance. Caffeine may increase the metabolism of other drugs such as phenobarbital and aspirin. Caffeine accumulation may occur when products or foods containing caffeine are consumed concomitantly with quinolones such as ciprofloxacin.
Information for Patients/Caregivers:
Patients receiving Acetaminophen, caffeine, and Makatussin Tropfen Forte bitartrate tablets should be given the following information:
Teratogenic Effects – Pregnancy Category C.
Animal reproduction studies have not been conducted with Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets. It is also not known whether this combination product can cause fetal harm when administered to pregnant women or can affect reproduction capacity in males and females. This combination product should be given to pregnant women only if clearly needed, especially during the first trimester.
Labor and Delivery:
Acetaminophen, caffeine, and Makatussin Tropfen Forte bitartrate tablets are not recommended for use by women during and immediately before labor and delivery because oral opioids may cause respiratory depression in the newborn.
Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate, acetaminophen and caffeine tablets are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from this combination product, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness of Acetaminophen, caffeine, and Makatussin Tropfen Forte bitartrate tablets in pediatric patients have not been established.
Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets should be given with caution to the elderly.
Acetaminophen, caffeine, and Makatussin Tropfen Forte bitartrate tablets should be given with caution to patients with hepatic insufficiency. Since Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) is metabolized by the liver and since acetaminophen potentially causes hepatotoxicity, the effects of this combination product should be monitored closely in such patients.
Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets should be used with caution and at reduced dosage in the presence of impaired renal function.
Pancreatic/Biliary Tract Disease:
Opioids may cause spasms of the sphincter of Oddi and should be used with caution in patients with biliary tract disease including pancreatitis.
Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride):
The most frequently observed adverse reactions include light-headedness, dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation, pruritus, and skin reactions. With the exception of constipation, tolerance develops to most of these effects. Other reactions that have been observed with Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) or other opioids include respiratory depression, orthostatic hypotension, cough suppression, confusion, diarrhea, miosis, abdominal pain, dry mouth, indigestion, anorexia, spasm of biliary tract, and urinary retention. Physical and psychological dependence are possibilities. Hypersensitivity reactions (including anaphylactoid reactions), hallucinations, vivid dreams, granulomatous interstitial nephritis, severe narcosis and acute renal failure have been reported rarely during Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) administration.
Acetaminophen in therapeutic doses rarely causes adverse reactions.
The most serious adverse reaction is hepatoxicity from overdosage (see OVERDOSAGE ). Thrombocytopenia, leukopenia, pancytopenia, neutropenia, thrombocytopenic purpura, and agranulocytosis have been reported in patients receiving acetaminophen or p-aminophenol derivatives. Hypersensitivity reactions including urticarial or erythematous skin reactions, laryngeal edema, angioedema, or anaphylactoid reactions are rare.
Adverse reactions associated with caffeine use include anxiety, anxiety neurosis, excitement, headaches, insomnia, irritability, lightheadedness, restlessness, tenseness, tremor, extrasystoles, palpitations, tachycardia, diarrhea, nausea, stomach pain, vomiting, diuresis, urticarcia, scintillating scotoma, and tinnitus.
DRUG ABUSE AND DEPENDENCE:
This combination product is subject to the provisions of the Controlled Substance Act, and has been placed in Schedule III.
Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) can produce drug dependence of the codeine type and therefore has the potential of being abused.
Like other opioid analgesics, Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) may produce subjective effects other than analgesia (e.g., euphoria, relaxation), which may contribute to abuse by some patients. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride), and It should be prescribed and administered with the same degree of caution appropriate to the use of other oral opioid analgesic medications.
Symptoms of Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) withdrawal consist of irritability, restlessness, insomnia, diaphoresis, anxiety and palpitations.
Prolonged, high intake of caffeine may produce tolerance and habituation. Physical signs of withdrawal, such as headaches, irritation, nervousness, anxiety, and dizziness may occur upon abrupt discontinuation.
Following an acute overdosage with Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets, toxicity may result from the Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride), acetaminophen, or, less likely, caffeine component. An overdose is a potentially lethal polydrug overdose situation, and consultation with a regional poison control center is recommended. A listing of the poison control centers can be found in standard references such as the Physician's Desk Reference®.
Signs and Symptoms and Laboratory Findings:
Toxicity from Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) is typical of opioids and includes pinpoint pupils, respiratory depression, and loss of consciousness. Convulsions, cardiovascular collapse, and death may occur. A single case of acute rhabdomyolysis associated with an overdose of Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) has been reported. With acetaminophen, dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may occur. Early symptoms of hepatotoxicity include nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours after ingestion. Acute caffeine poisoning may cause insomnia, restlessness, tremor, delirium, tachycardia, extrasystoles, and seizures.
Because overdose information on this combination product is limited, it is unclear which of the signs and symptoms of toxicity would manifest in any particular overdose situation.
Immediate treatment of an overdosage of Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced with syrup of ipecac, if the patient is alert and has adequate laryngeal reflexes. Oral activated charcoal should follow. The first dose of charcoal should be accompanied by an appropriate cathartic. Gastric lavage may be necessary. Hypotension is usually hypovolemic and should be treated with fluids. Endotracheal intubation and artificial respiration may be necessary. Peritoneal or hemodialysis may be necessary. If hypoprothrombinemia occurs, Vitamin K should be administered.
A pure opioid antagonist, such as naloxone or nalmefene, is a specific antidote against respiratory depression which results from opioid overdose. Opioid antagonists should not be given in the absence of clinically significant respiratory or circulatory depression secondary to opioid overdose. They should be administered cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The prescribing information for the specific opioid antagonist should be consulted for details of their proper use.
In adults and adolescents, regardless of the quantity of acetaminophen reported to have been ingested, acetylcysteine should be administered immediately if 24 hours or less have elapsed from the reported time of ingestion. It is not advisable to await the plasma concentration determination of acetaminophen before administering acetylcysteine. Serum liver enzyme levels should be measured. Therapy in children involves a similar treatment scheme; however, a regional Poison Control Center should be contacted. No specific antidote is available for caffeine. In addition to the supportive measures above, administration of demulcents such as aluminum hydroxide gel may diminish gastrointestinal irritation. Seizures may be treated with intravenous diazepam or a barbiturate.
DOSAGE AND ADMINISTRATION
The usual adult dosage is one (1) Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than one (1) tablet should be taken in a 4-hour period. No more than five (5) doses, or five (5) tablets should be taken in a 24-hour period.
Acetaminophen, caffeine, and Makatussin Tropfen Forte (Dihydrocodeine Hydrochloride) bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in
Store at 20°C to 25°C (68°F to 77°F).. Protect from moisture.
Dispense in a tight, light-resistant container with a child-resistant closure.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Boca Pharmacal, Inc.
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Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc.
Relabeling and Repackaging by:
Physicians Total Care, Inc.
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Makatussin Tropfen Forte pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Makatussin Tropfen Forte available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Makatussin Tropfen Forte destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Makatussin Tropfen Forte Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Makatussin Tropfen Forte pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Makatussin Tropfen Forte?
Depending on the reaction of the Makatussin Tropfen Forte after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Makatussin Tropfen Forte not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Makatussin Tropfen Forte addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
ReviewsDrugs.com conducted a study on Makatussin Tropfen Forte, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Makatussin Tropfen Forte consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
One visitor reported usefulHow is the drug Makatussin Tropfen Forte useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sDrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
One visitor reported side effectsDid you get side effects while taking the Makatussin Tropfen Forte drug, or were there no side effects?
According to the survey conducted by website sDrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Makatussin Tropfen Forte medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
One visitor reported price estimatesWhat is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sDrugs.com website users shows the following figures about several people who felt the medicine Makatussin Tropfen Forte is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
One visitor reported frequency of useHow often in a day do you take the medicine?
Are you taking the Makatussin Tropfen Forte drug as prescribed by the doctor?
Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sDrugs.com website users about the frequency of taking the drug Makatussin Tropfen Forte is mentioned below.
One visitor reported dosesWhat is the dose of Makatussin Tropfen Forte drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 501mg-1g. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
One visitor reported administrationThe drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Makatussin Tropfen Forte drug, before food or after food?
Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
One visitor reported age
The information was verified by Dr. Arunabha Ray, MD Pharmacology