Spasmo PROXYVON PLUS Overdose

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Consists of dicyclomine, paracetamol, tramadol

What happens if I overdose Dicyclomine (Spasmo PROXYVON PLUS)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include convulsions (seizures); difficulty breathing; dilated pupils; disorientation; excessive thirst; flushed, hot, dry skin; hallucinations or unusual behavior; muscle weakness; nausea; rapid heartbeat and breathing; restlessness; severe dizziness or drowsiness; severe dry mouth; vomiting.

Proper storage of Dicyclomine (Spasmo PROXYVON PLUS):

Store at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dicyclomine (Spasmo PROXYVON PLUS) out of the reach of children and away from pets.

Overdose of Dicyclomine (Spasmo PROXYVON PLUS) in details

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In case of an overdose, patients should contact a physician, poison control centre (1-800-222-1222), or emergency room.

The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

One reported event included a 37-year-old who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets four times daily.) These events resolved after discontinuing the Dicyclomine (Spasmo PROXYVON PLUS).

The acute oral LD of the drug is 625 mg/kg in mice.

The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride, the blood concentrations of drug were 200, 220, and 505 ng/mL.

It is not know if Dicyclomine (Spasmo PROXYVON PLUS) is dialyzable.

Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

What should I avoid while taking Dicyclomine (Spasmo PROXYVON PLUS)?

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Dicyclomine (Spasmo PROXYVON PLUS) can cause decreased sweating, which can lead to heat stroke in a hot environment.

Drinking alcohol can increase certain side effects of Dicyclomine (Spasmo PROXYVON PLUS).

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb Dicyclomine (Spasmo PROXYVON PLUS).

Dicyclomine (Spasmo PROXYVON PLUS) warnings

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In the presence of a high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and supportive measures instituted.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.

Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride oral solution may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

Psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.

These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.

There are reports that administration of Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride oral solution to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea, asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma. Death has been reported. No causal relationship between these effects observed in infants and Dicyclomine (Spasmo PROXYVON PLUS) administration has been established. Dicyclomine (Spasmo PROXYVON PLUS) HYDROCHLORIDE ORAL SOLUTION IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS..

Safety and efficacy of Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride in pediatric patients have not been established.

What should I discuss with my healthcare provider before taking Dicyclomine (Spasmo PROXYVON PLUS)?

Some medical conditions may interact with Dicyclomine (Spasmo PROXYVON PLUS). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Dicyclomine (Spasmo PROXYVON PLUS). Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dicyclomine (Spasmo PROXYVON PLUS) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Dicyclomine (Spasmo PROXYVON PLUS) precautions

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Inadvertent

Intravenous Administration

Dicyclomine (Spasmo PROXYVON PLUS) solution is for intramuscular administration only. Do not administer by any other route. Inadvertent intravenous administration may result in thrombosis, thrombophlebitis and injection site reactions such as pain, edema, skin color change, and reflex sympathetic dystrophy syndrome.

Cardiovascular Conditions

Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension.

Peripheral And Central Nervous System

The peripheral effects of Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation.

In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted. Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy.

Central nervous system (CNS) signs and symptoms include confusional state, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.

Psychosis and delirium have been reported in sensitive individuals (such as elderly patients and/or in patients with mental illness) given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.

Dicyclomine (Spasmo PROXYVON PLUS) may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking Dicyclomine (Spasmo PROXYVON PLUS).

Myasthenia Gravis

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase

Intestinal Obstruction

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.

Rarely development of Ogilvie's syndrome (colonic pseudo-obstruction) has been reported. Ogilvie's syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction

Toxic Dilatation Of Intestinemegacolon

Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.

Ulcerative Colitis

Caution should be taken in patients with ulcerative colitis. Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon. Dicyclomine (Spasmo PROXYVON PLUS) is contraindicated in patients with severe ulcerative colitis.

Prostatic Hypertrophy

Dicyclomine (Spasmo PROXYVON PLUS) should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention

Hepatic And Renal Disease

Dicyclomine (Spasmo PROXYVON PLUS) should be used with caution in patients with known hepatic and renal impairment.

Geriatric Population

Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of Dicyclomine (Spasmo PROXYVON PLUS). In studies in rats at doses of up to 100 mg/kg/day, Dicyclomine (Spasmo PROXYVON PLUS) produced no deleterious effects on breeding, conception, or parturition.

Use In Specific Populations

Pregnancy

Pregnancy Category B

Adequate and well-controlled studies have not been conducted with Dicyclomine (Spasmo PROXYVON PLUS) in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations amoung babies born to women who took products containing Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy.

Reproduction studies have been performed in rats and rabbits at doses of up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to Dicyclomine (Spasmo PROXYVON PLUS). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Dicyclomine (Spasmo PROXYVON PLUS) is contraindicated in women who are breastfeeding. Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants from Dicyclomine (Spasmo PROXYVON PLUS), a decision should be made whether to discontine nursing or to discontinue the drug, taking into account the importance of the drug to the mother..

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Dicyclomine (Spasmo PROXYVON PLUS) is contraindicated in infants less than 6 months of age. There are published cases reporting that the administration of Dicyclomine (Spasmo PROXYVON PLUS) hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.

Geriatric Use

Clinical studies of Dicyclomine (Spasmo PROXYVON PLUS) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Renal Impairment

Effects of renal impairment on PK, safety and efficacy of Dicyclomine (Spasmo PROXYVON PLUS) have not been studied. Dicyclomine (Spasmo PROXYVON PLUS) drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicyclomine (Spasmo PROXYVON PLUS) should be administered with caution in patients with renal impairment.

Hepatic Impairment

Effects of renal impairment on PK, safety and efficacy of Dicyclomine (Spasmo PROXYVON PLUS) have not been studied. Dicyclomine (Spasmo PROXYVON PLUS) should be administered with caution in patients with hepatic impairment.

What happens if I miss a dose of Dicyclomine (Spasmo PROXYVON PLUS)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose Paracetamol (Spasmo PROXYVON PLUS)?

Seek emergency medical attention if you think you have used too much of this medicine.

The first signs of an Paracetamol (Spasmo PROXYVON PLUS) overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose of Paracetamol (Spasmo PROXYVON PLUS) in details

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Paracetamol (Spasmo PROXYVON PLUS) in massive overdosage may cause hepatic toxicity in some patients. In adults and children >12 years, hepatic toxicity may occur following ingestion of >7.5-10 g over a period of ≤8 hrs. Fatalities are infrequent (<3-4% of untreated cases) and have rarely been reported with overdoses of <15 g. In children <12 years, acute overdosage with Paracetamol (Spasmo PROXYVON PLUS) <150 mg/kg body weight have not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: Nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48-72 hrs after ingestion. In adults and children >12 years, any individual presenting with an unknown amount of Paracetamol (Spasmo PROXYVON PLUS) ingested or with a questionable or unreliable history about the time of ingestion should have a plasma Paracetamol (Spasmo PROXYVON PLUS) level drawn and be treated with N-acetylcysteine. Do not await results of assays for plasma Paracetamol (Spasmo PROXYVON PLUS) levels before initiating treatment with N-acetylcysteine. The following additional procedures are recommended. Promptly initiate decontamination of the stomach. A plasma Paracetamol (Spasmo PROXYVON PLUS) assay should be obtained as early as possible, but not sooner than 4 hrs following ingestion. Liver function studies should be obtained initially and repeated at 24-hr intervals.

Serious toxicity or fatalities have been extremely infrequent following acute overdosage in young children, possibly because of differences in the way they metabolize Paracetamol (Spasmo PROXYVON PLUS). In children, the maximum potential amount ingested can be more easily estimated. If >150 mg/kg or an unknown amount of Paracetamol (Spasmo PROXYVON PLUS) was ingested, obtain a plasma Paracetamol (Spasmo PROXYVON PLUS) level as soon as possible but no sooner than 4 hrs following ingestion. If an assay cannot be obtained and the estimated Paracetamol (Spasmo PROXYVON PLUS) ingestion exceeds 150 mg/kg, dosing with N-acetylcysteine should be initiated and continued for a full course of therapy.

What should I avoid while taking Paracetamol (Spasmo PROXYVON PLUS)?

Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Paracetamol (Spasmo PROXYVON PLUS) is contained in many combination medicines. If you use certain products together you may accidentally use too much Paracetamol (Spasmo PROXYVON PLUS). Read the label of any other medicine you are using to see if it contains Paracetamol (Spasmo PROXYVON PLUS), acetaminophen or APAP. Avoid drinking alcohol while taking this medication. Alcohol may increase your risk of liver damage while taking Paracetamol (Spasmo PROXYVON PLUS).

Paracetamol (Spasmo PROXYVON PLUS) warnings

Paracetamol (Spasmo PROXYVON PLUS) Sante Naturelle is used with caution in patients with hyperoxaluria, renal impairment, a history of instructions on urolithiasis. Because ascorbic acid increases iron absorption, its use in high doses can be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.

Patients with high content body iron should apply ascorbic acid in minimal doses.

Paracetamol (Spasmo PROXYVON PLUS) Sante Naturelle is used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase.

The use of ascorbic acid in high doses can cause exacerbation of sickle cell anemia.

Data on the diabetogenic Paracetamol (Spasmo PROXYVON PLUS) of ascorbic acid are contradictory. However, prolonged use of ascorbic acid should periodically monitor your blood glucose levels.

It is believed that the use of ascorbic acid in patients with rapidly proliferating and widely disseminated tumors may worsen during the process. It should therefore be used with caution in ascorbic acid in patients with advanced cancer.

Absorption of ascorbic acid decreased while use of fresh fruit or vegetable juices, alkaline drinking.

What should I discuss with my healthcare provider before taking Paracetamol (Spasmo PROXYVON PLUS)?

Do not use this medication if you are allergic to acetaminophen or Paracetamol (Spasmo PROXYVON PLUS).

Ask a doctor or pharmacist if it is safe for you to take Paracetamol (Spasmo PROXYVON PLUS) if you have:

It is not known whether Paracetamol (Spasmo PROXYVON PLUS) will harm an unborn baby. Before using Paracetamol (Spasmo PROXYVON PLUS), tell your doctor if you are pregnant. This medication can pass into breast milk and may harm a nursing baby. Do not use Paracetamol (Spasmo PROXYVON PLUS) without telling your doctor if you are breast-feeding a baby.

Paracetamol (Spasmo PROXYVON PLUS) precautions

Care is advised in the administration of Paracetamol (Spasmo PROXYVON PLUS) to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not take more medicine than the label instructed. If the patient did not get better, talk to the physician.

Do not take anything else containing Paracetamol (Spasmo PROXYVON PLUS) while taking Paracetamol (Spasmo PROXYVON PLUS).

Inform the physician at once if the patient take too much of Paracetamol (Spasmo PROXYVON PLUS), even if the patient feel well. This is because too much Paracetamol (Spasmo PROXYVON PLUS) can cause delayed, serious liver damage.

Patients should be advised that Paracetamol (Spasmo PROXYVON PLUS) may cause severe skin reactions. If a skin reaction eg, skin reddening, blisters or rash occurs, they should stop use and seek medical assistance right away.

Use in pregnancy & lactation: Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol (Spasmo PROXYVON PLUS) used in the recommended dosage, but patients should follow the advice of the physician regarding its use. Paracetamol (Spasmo PROXYVON PLUS) is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.

What happens if I miss a dose of Paracetamol (Spasmo PROXYVON PLUS)?

Since Paracetamol (Spasmo PROXYVON PLUS) is often used only when needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next regularly scheduled dose, skip the missed dose and use your next dose as directed. Do not use extra medicine to make up for a missed dose.

What happens if I overdose Tramadol (Spasmo PROXYVON PLUS)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Tramadol (Spasmo PROXYVON PLUS):

Store Tramadol (Spasmo PROXYVON PLUS) at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tramadol (Spasmo PROXYVON PLUS) out of the reach of children and away from pets.

Overdose of Tramadol (Spasmo PROXYVON PLUS) in details

Symptoms

Symptoms of overdosage with Tramadol (Spasmo PROXYVON PLUS)® are respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures, bradycardia, hypotension, cardiac arrest, and death.

Deaths due to overdose have been reported with abuse and misuse of Tramadol (Spasmo PROXYVON PLUS). Review of case reports has indicated that the risk of fatal overdose is further increased when Tramadol (Spasmo PROXYVON PLUS) is abused concurrently with alcohol or other CNS depressants, including other opioids.

Treatment

A single or multiple overdose with Tramadol (Spasmo PROXYVON PLUS)® may be a potentially lethal polydrug overdose, and consultation with a regional poison control centre is recommended.

In treating an overdose of Tramadol (Spasmo PROXYVON PLUS)®, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

While naloxone will reverse some, but not all, symptoms caused by overdosage with Tramadol (Spasmo PROXYVON PLUS), the risk of seizures is also increased with naloxone administration. Seizures may be controlled with diazepam.

In animals, convulsions following the administration of toxic doses of Tramadol (Spasmo PROXYVON PLUS) could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice.

Based on experience with Tramadol (Spasmo PROXYVON PLUS), hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.

Emptying of the gastric contents is useful to remove any unabsorbed drug.

What should I avoid while taking Tramadol (Spasmo PROXYVON PLUS)?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Tramadol (Spasmo PROXYVON PLUS). Check your food and medicine labels to be sure these products do not contain alcohol.

Tramadol (Spasmo PROXYVON PLUS) may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Tramadol (Spasmo PROXYVON PLUS) warnings

Seizure Risk

Seizures have been reported in patients receiving Tramadol (Spasmo PROXYVON PLUS) hydrochloride within the recommended dosage range. Spontaneous postmarketing reports indicate that seizure risk is increased with doses above the recommended range. Concomitant use of Tramadol (Spasmo PROXYVON PLUS) hydrochloride increases the seizure risk in patients taking:

Administration of Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) may enhance the seizure risk in patients taking:

Risk of convulsions may also be increased in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, certain metabolic disorders, alcohol and drug withdrawal and CNS infections). In Tramadol (Spasmo PROXYVON PLUS) overdose, naloxone administration may increase the risk of seizures.

Suicide Risk

Do not prescribe Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) for patients who are suicidal or addiction-prone. Prescribe Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) with caution for patients taking tranquilizers or antidepressant drugs and for patients who use alcohol in excess. Serious potential consequences of overdosage with Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment.

Serotonin Syndrome risk

The development of a potentially life-threatening serotonin syndrome may occur with the use of Tramadol (Spasmo PROXYVON PLUS) products, including Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets), particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs, and triptans, with drugs which impair metabolism of serotonin (including MAOIs), and with drugs which impair metabolism of Tramadol (Spasmo PROXYVON PLUS) (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose.

Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Tramadol (Spasmo PROXYVON PLUS) products in excessive doses, either alone or in combination with other Central Nervous System (CNS) depressants, including alcohol, are a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon. Tramadol (Spasmo PROXYVON PLUS) should not be taken in doses higher than those recommended by the physician. The judicious prescribing of Tramadol (Spasmo PROXYVON PLUS) is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of Tramadol (Spasmo PROXYVON PLUS) products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, Tramadol (Spasmo PROXYVON PLUS) should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations.

Many of the Tramadol (Spasmo PROXYVON PLUS)-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of Tramadol (Spasmo PROXYVON PLUS) alone or in combination with other drugs. Patients taking Tramadol (Spasmo PROXYVON PLUS) should be warned not to exceed the dose recommended by their physician.

Anaphylactoid Reactions

Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with Tramadol (Spasmo PROXYVON PLUS). When these events do occur, it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to other opioids may be at increased risk and therefore should not receive Tramadol (Spasmo PROXYVON PLUS)™.

Respiratory Depression

Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) should be administered cautiously in patients at risk for respiratory depression. In these patients, alternative non-opioid analgesics should be considered. When large doses of Tramadol (Spasmo PROXYVON PLUS) are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.

Interaction with Central Nervous System (CNS) Depressants

Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Tramadol (Spasmo PROXYVON PLUS) increases the risk of CNS and respiratory depression in these patients.

Increased Intracranial Pressure or Head Trauma

Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from Tramadol (Spasmo PROXYVON PLUS) may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets).

Use in Ambulatory Patients

Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) may impair the mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Patients using this drug should be cautioned accordingly.

Use with MAO Inhibitors and Serotonin Re-uptake Inhibitors

Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) should be used with great caution in patients taking MAO inhibitors. Animal studies have shown increased deaths with combined administration of Tramadol (Spasmo PROXYVON PLUS) and MAO inhibitors. Concomitant use of Tramadol (Spasmo PROXYVON PLUS) products with MAO inhibitors or SSRIs increases the risk of adverse events, including seizure and serotonin syndrome.

Withdrawal

Withdrawal symptoms may occur if Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations.

In a 12 week study, 325 patients were followed for 3 and 7 days after discontinuation of treatment with Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets). The majority of reported post-treatment adverse events including withdrawal symptoms were mild to moderate in nature. Onset of the post-treatment adverse events occurred more frequently within the first three days after treatment was stopped. Less than 1% of patients taking Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) met the DSM-IV criteria for a diagnosis of opioid withdrawal.

Clinical experience suggests that signs and symptoms of withdrawal may be reduced by tapering medication when discontinuing Tramadol (Spasmo PROXYVON PLUS) therapy.

Misuse, Abuse and Diversion of Opioids

Tramadol (Spasmo PROXYVON PLUS) is an opioid agonist of the morphine type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Like other opioid agonists, legal or illicit, Tramadol (Spasmo PROXYVON PLUS) can be abused. This should be considered when prescribing or dispensing Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) in situations where the healthcare professional is concerned about a risk of misuse, abuse, or diversion.

Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) could be abused by breaking, crushing, chewing, or dissolving the product which can result in the uncontrolled delivery of the opioid, and as a consequence poses a significant risk of overdose and death.

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Interactions with Alcohol and Drugs of Abuse

Tramadol (Spasmo PROXYVON PLUS) may be expected to have additive effects when used in conjunction with alcohol, other opioids or drugs, whether legal or illicit, which cause central nervous system depression.

What should I discuss with my healthcare provider before taking Tramadol (Spasmo PROXYVON PLUS)?

You should not take Tramadol (Spasmo PROXYVON PLUS) if you are allergic to Tramadol (Spasmo PROXYVON PLUS), or if you have:

Seizures have occurred in some people taking Tramadol (Spasmo PROXYVON PLUS). Talk with your doctor about your seizure risk, which may be higher if you have:

Some medicines can interact with Tramadol (Spasmo PROXYVON PLUS) and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure Tramadol (Spasmo PROXYVON PLUS) is safe for you, tell your doctor if you have:

Tramadol (Spasmo PROXYVON PLUS) is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Tramadol (Spasmo PROXYVON PLUS) may be habit forming and should be used only by the person it was prescribed for. Never share Tramadol (Spasmo PROXYVON PLUS) with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Tramadol (Spasmo PROXYVON PLUS) to any other person is against the law.

It is not known whether Tramadol (Spasmo PROXYVON PLUS) will harm an unborn baby. If you use Tramadol (Spasmo PROXYVON PLUS) while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Tramadol (Spasmo PROXYVON PLUS) can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking Tramadol (Spasmo PROXYVON PLUS).

Do not give this medication to anyone younger than 16 years old without the advice of a doctor. Tramadol (Spasmo PROXYVON PLUS) ER should not be given to anyone younger than 18 years old.

Tramadol (Spasmo PROXYVON PLUS) precautions

Acute Abdominal Conditions

The administration of Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) may complicate the clinical assessment of patients with acute abdominal conditions.

Use in Renal and Hepatic Disease

Impaired renal function results in a decreased rate and extent of excretion of Tramadol (Spasmo PROXYVON PLUS) and its active metabolite, M1 in patients taking an immediate-release formulation of Tramadol (Spasmo PROXYVON PLUS). Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) has not been studied in patients with renal impairment. The limited availability of dose strengths and once daily dosing of Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Therefore, Tramadol (Spasmo PROXYVON PLUS) (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) ™ should not be used in patients with severe renal impairment

The metabolism of Tramadol (Spasmo PROXYVON PLUS) and M1 is reduced in patients with advanced cirrhosis of the liver. Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) has not been studied in patients with hepatic impairment. The limited availability of dose strengths and once daily dosing of Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) do not permit the dosing flexibility required for safe use in patients with hepatic impairment. Therefore, Tramadol (Spasmo PROXYVON PLUS)™ should not be used in patients with hepatic impairment

Use in Drug and Alcohol Addiction

Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) is an opioid with no approved use for the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission is for the management of pain requiring opioid analgesia.

Carcinogenesis, Mutagenesis and Impairment of Fertility

A slight, but statistically significant increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m or 2.6 times the maximum daily human dose).

There are no adequate and well-controlled studies in pregnant women. Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and stillbirth have been reported during post-marketing surveillance of Tramadol (Spasmo PROXYVON PLUS) immediate-release products.

Labor and Delivery

Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn. Tramadol (Spasmo PROXYVON PLUS) has been shown to cross the placenta. The mean ratio of serum Tramadol (Spasmo PROXYVON PLUS) in the umbilical veins compared to maternal veins was 0.83 for 40 women given Tramadol (Spasmo PROXYVON PLUS) during labor.

The effect of Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets), if any, on the later growth, development and functional maturation of the child is unknown.

Nursing Mother

Tramadol (Spasmo PROXYVON PLUS)™ (Tramadol (Spasmo PROXYVON PLUS) hydrochloride extended-release tablets) is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of Tramadol (Spasmo PROXYVON PLUS), the cumulative excretion in breast milk within 16 hours postdose was 100

What happens if I miss a dose of Tramadol (Spasmo PROXYVON PLUS)?

Since Tramadol (Spasmo PROXYVON PLUS) is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.



References

  1. DrugBank. "dicyclomine". http://www.drugbank.ca/drugs/DB00804 (accessed September 17, 2018).
  2. DrugBank. "Tramadol". http://www.drugbank.ca/drugs/DB00193 (accessed September 17, 2018).
  3. MeSH. "Parasympatholytics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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