LAMALINE is an ANTALGIC (it calms the pains). It is intended for the treatment in adults of pain of moderate to intense intensity and / or which is not relieved by aspirin or paracetamol alone.
lamaline drug indication and Uses
RESERVED FOR ADULTS
- Like all analgesic medications, the dosage of LAMALINE must be adapted to the intensity of the pain and the clinical response of each patient.
- The usual dosage is 1 suppository, 2 to 3 times a day, without exceeding 6 suppositories per day.
- The catches must be spaced at least 4 hours apart.
- To avoid the risk of overdose, check the absence of paracetamol in the composition of other associated drugs. THE TOTAL DOSE OF PARACETAMOL SHOULD NOT EXCEED 4 GRAMS PER DAY (see section Overdose ).
- The total daily dose of paracetamol should not exceed 3 grams / day in the following situations: Weight <50kg, mild to moderate hepatocellular insufficiency, severe renal insufficiency (creatinine clearance <10ml / min), chronic alcoholism, chronic undernutrition, fasting prolonged, elderly subject.
- Renal impairment: In severe renal impairment (creatinine clearance less than 10 ml / min), the interval between two doses will be at least 8 hours.
lamaline drug Contraindications
- – Hypersensitivity to one of the components of the specialty.
- – Hepatocellular insufficiency.
- – Child under 15 years old.
- – Pregnancy, breast-feeding: do not administer to pregnancy or breast-feeding due to the presence of opium .
- – Combination with morphine agonists-antagonists (nalbuphine, buprenorphine, pentazocine).
- Absorption of alcohol is not recommended during treatment.
how it works lamaline drug?
– Paracetamol :
- . Prolonged rectal absorption.
- . The bioavailability of the rectal route is comparable to that of the oral route.
- . Rapid distribution to fluid environments.
- . Low binding to plasma proteins.
- . Peak plasma reached in about 2 hours 30 minutes.
- . Plasma half-life of elimination of the order of 4 hours.
. Hepatic metabolism:
- Paracetamol follows two major metabolic pathways. It is eliminated in the urine in the form of glucuronjugate (60 to 80 percent) and sulphoconjugate (20 to 30 percent) and for less than 5 percent in unchanged form.
- A small fraction (less than 4 percent) is transformed by cytochrome P450 into a metabolite that is conjugated with glutathione. During massive intoxications, the amount of this metabolite is increased.
- . Recent evidence does not suggest that paracetamol metabolism is altered in hepatic impairment.
- . Paracetamol is eliminated in conjugated form; the conjugacy capacity is not modified in the elderly.
PHYSIOPATHOLOGICAL VARIATIONS :
- Renal insufficiencyIn patients with severe renal impairment (creatinine clearance less than 10 ml / min), paracetamol and its metabolites are delayed.
– CAFEIN :
- It is quickly and completely absorbed. Peak plasma concentrations are usually reached within minutes to 60 minutes after ingestion. It is metabolized by the liver, its elimination is urinary.
LAMALINE Side Effects
RELATED TO PARACETAMOL
The following side effects have been reported in patients treated with paracetamol alone:
- · Few hypersensitivity reactions such as anaphylactic shock, Quincke’s disease, erythema, urticaria, cutaneous rashes. Their occurrence requires the definitive discontinuation of this drug and related drugs.
- · Very rare cases of serious skin reactions (eg, Stevens Johnson and Lyell syndrome, bullous toxidermias, acute exanthematous pustulosis). Their occurrence requires the definitive discontinuation of this drug and related drugs.
- · Very exceptional cases of thrombocytopenia, leukopenia and neutropenia have been reported.
RELATED TO DOPIUM LEXTRIT
The adverse effects of the dopamine extract are comparable to those of other opiates. Possibility of :
- · Drowsiness, confusion, sedation, excitement, euphoria, dysphoria, nightmares, especially in the elderly, with possibly hallucinations.
- · Respiratory depression, bronchospasm .
- · Increased intracranial pressure.
- · Nausea, vomiting, constipation.
- · Acute biliary or pancreatic abdominal pain syndrome, suggestive of OdiD sphincter spasm, occurring particularly in cholecystectomized patients.
- · Acute pancreatitis
- · Myosis, vertiginous states.
- · Dysuria and urinary retention.
- · Itching, hives and rash.
- · Hyperalgesia: In the event of increased sensitivity to pain or worsening of initial pain after an increase in the dose of therapy or if abnormal pain, quality and anatomical localization differ from the initial pain, treatment should be stopped.
- Drug dependence and withdrawal syndrome (during prolonged use at supra-therapeutic doses).
- Possibility of excitement, insomnia and palpitations.
Associations subject to precautions for use
- Risk of increased effect of oral anticoagulant and haemorrhagic risk when taking paracetamol at maximum doses (4 g / day) for at least 4 days.
- Regular control of the INR. Possible adaptation of oral anticoagulant dosage during paracetamol treatment and after discontinuation.
Interference with paraclinical exams
- Taking paracetamol may interfere with the glucose-glucose oxidase-peroxidase assay at abnormally high concentrations.
- Taking paracetamol may interfere with the determination of blood uric acid by the phosphotungstic acid method.
RELATED TO OPIUM
Morphonic agonists-antagonists (nalbuphine, buprenorphine, pentazocine):
- Decrease of the analgesic effect by competitive blocking of the receptors with risk of appearance of a withdrawal syndrome.
Morphic Partial Antagonists (Naltrexone, Nalmefene):
- Risk of reduction of the analgesic effect
- Associations advised against
Alcohol (drink or excipient):
- Alcohol enhancement of the sedative effect of opioid analgesics. Altered alertness can make driving and using machines more dangerous.
- Avoid taking alcoholic drinks and drugs containing alcohol.
Associations to consider
Other agonistic morphine-like analgesics, morphine-like antitussives, true morphine antitussives, barbiturates, benzodiazepines and related:
- Increased risk of respiratory depression, which can be fatal in case of overdose.
Other CNS depressants: sedative antidepressant, sedative antihistamine H1, anxiolytic and hypnotic, neuroleptic, clonidine and related, thalidomide:
- Increase of the central depression. Altered alertness can make driving and using machines more dangerous.
RELATED TO CAFEINE
Associations advised against
- Increased plasma concentrations of caffeine that can cause excitations and hallucinations, by decreasing its hepatic metabolism.
Associations requiring precaution of use
- With dipyridamole for injection: reduction of the vasodilatory effect of dipyridamole by caffeine. Discontinue caffeine-based therapy at least 5 days prior to myocardial imaging with dipyridamole and avoid consumption of coffee, tea, chocolate or cola within 24 hours of the test.
Associations to consider
- In case of abrupt cessation of coffee consumption or caffeine-containing drugs, risk of increased lithium
Mexiletine, Norfloxacine, Ciprofloxacin
- Increased plasma caffeine levels by decreasing hepatic metabolism.
LAMALINE Warnings and Precautions
This medicine contains paracetamol. To avoid the risk of overdose, check the absence of paracetamol in the composition of other associated drugs. THE TOTAL DOSE OF PARACETAMOL SHOULD NOT EXCEED 4 GRAMS PER DAY (see section Overdose ). In the following situations, the total dose of 3 grams / day should not be exceeded (see section Dosage and method of administration ):
- o Weight <50kg,
- o mild to moderate hepatocellular insufficiency,
- o severe renal insufficiency (creatinine clearance <10ml / min),
- o chronic alcoholism,
- o chronic undernutrition,
- o prolonged fasting
- o elderly
- Prolonged use at doses higher than those recommended may lead to drug dependence.
- In predisposed patients, treatment should be under medical supervision.
- LAMALINE should be used only after a careful evaluation of the benefit-risk ratio, depending on the origin of the pain and the patient’s profile.
Precautions for use
- It is recommended not to exceed the recommended doses and to respect the minimum interval of administration.
- In the elderly and the elderly, sensitivity to analgesic effects but also to central (confusional) or digestive effects, combined with a decrease in renal function, should encourage caution.
- The dosage should be reduced by increasing the interval between shots.
Patients with renal insufficiency
- The dosage should be reduced by increasing the interval between
Patients with hepatocellular insufficiency
- LAMALINE is not recommended in patients with mild to moderate hepatocellular insufficiency due to the lack of evaluation in this population.
- Opium extract can precipitate or aggravate encephalopathy. (see Contraindications section )
Subjects with G6PD deficiency
- Cases of acute haemolysis have been reported in these patients with high doses of paracetamol, ie above the maximum daily recommended dosage. It is important to respect the dosages.
- If acute viral hepatitis is found, treatment should be discontinued.
- Alcohol absorption is not recommended during treatment.
- Because of the presence of opium, a urethroporatic or bladder pathology, common in the elderly, exposes to the risk of urinary retention.
- In case of intracranial hypertension, opium extract may increase the importance of this hypertension.
- The co-prescription of psychotropic treatments, CNS depressants or with an anti-cholinergic effect increases the occurrence of adverse effects. (see section Interactions with other drugs and other forms of interaction )
- It is imperative to ensure the absence of occlusive syndrome before starting treatment. Constipation is a known side effect of opium extract.
- In the cholecystectomized patient, opium extract can cause an acute abdominal pain syndrome of biliary or pancreatic type, most often associated with biological abnormalities, suggestive of a spasm of the sphincter of Oddi.
- In case of productive cough, opium extract can hinder sputum.
- Due to the presence of caffeine, this medicine can cause insomnia, avoid taking late in the day.
- The attention of athletes must be drawn to the fact that this specialty contains morphine and that this active ingredient is included in the list of doping substances.
Drive and use machines
Risk of drowsiness, especially for vehicle drivers and machine users.
LAMALINE and PREGNANCY / BREAST FEEDING / FERTILITY
- The presence of opium extract determines the course of action.
- Studies in animals have shown a teratogenic effect of certain substances contained in the opium extract (eg morphine, codeine).
There are no clinical data of sufficient relevance to evaluate the malformation risk of this drug in humans. If administered late in pregnancy, consider the morphinomimetic properties of this drug and consider neonatal monitoring:
- Risk of withdrawal syndrome in case of chronic administration at the end of pregnancy, whatever the dose;
- Theoretical risk of respiratory depression in the neonate after high doses, even in brief treatment, before or during delivery.
- Therefore, LAMALINE suppository should not be used during pregnancy unless absolutely necessary.
- The passage of this specialty in breast milk is not known. However, due to the presence of morphinomimetic derivatives and the passage of morphine in breast milk, this drug is contraindicated during breastfeeding.
Do not take a double dose to make up for the dose you forgot to take.
What happens if I overdose from LAMALINE ?
- The risk of serious intoxication (therapeutic overdose or frequent accidental poisoning), which can lead to severe, potentially fatal liver failure, is particularly high in the elderly, in young children and adolescents, in patients with liver disease, chronic alcoholism, in malnourished patients, in patients under 50 kg.
- · Symptoms
- · At an early stage, detoxification may be completely asymptomatic.
- · Usually within the first 24 hours, nausea, vomiting, anorexia, paleness, abdominal pain occur.
- · Within 12 to 48 hours after ingestion, there may be an increase in hepatic transaminases, lactic dehydrogenase, bilirubin and a decrease in prothrombin levels.
- · Overdose may result in hepatic cytolysis which may lead to hepatocellular failure, metabolic acidosis, encephalopathy up to coma, and death. Renal toxic damage with acute tubular necrosis and renal failure may occur even in the absence of hepatic insufficiency.
- · Hyperamylasemia and more rarely acute pancreatitis have been observed.
- · Cardiac arrhythmias have been reported.
- · Immediate transfer to hospital.
- · Collect a tube of blood to do the initial plasma paracetamol test.
- · Rapid evacuation of the product ingested by gastric lavage.
- · The treatment of overdose typically comprises the administration as early as possible of the antidote N-acetylcysteine IV or oral route if possible before the tenth hour.
- · Symptomatic treatment.
RELATED TO DOPIUM LEXTRAIT:
- Mild to moderate overdose: euphoria, drowsiness, constipation, nausea, vomiting and miosis. Bradycardia or mild hypotension may be present.
- Severe overdose: a respiratory depression that may lead to apnea, hypoxia, coma, bradycardia, or acute lung injury. Rarely, convulsive seizures can occur following the occurrence of hypoxia. Acute tubular necrosis secondary to rhabdomyolysis and myoglobinuria may occur in patients with prolonged coma or convulsions. These complications can lead to death.
An overdose of opioids can be life-threatening. Administration of activated charcoal should be considered promptly after significant oral ingestion, if the patient can protect the respiratory tract and show no severe signs of toxicity. If a patient exhibits signs of moderate to severe toxicity, activated charcoal should not be given because of the risk of inhalation.
· Management of mild to moderate intoxication
Patient monitoring may be sufficient.
· Management of severe intoxication:
- Intensive supportive treatment may be necessary to correct respiratory failure and shock. In addition, the naloxone-specific antagonist is used to rapidly reverse severe respiratory depression and coma caused by excessive doses of opioid analgesics. Since naloxone has a shorter duration of action than many dopoids, many responders should be kept under close surveillance for signs of relapse and repeated injections should be made based on the respiratory rate and the severity of the coma.
- Alternatively, in situations where repeated administration is necessary, for example when a long-acting opioid is the cause or is suspected to be the cause of the symptoms, a continuous intravenous infusion of naloxone can be performed and will be adapted to the response.
- All patients should be monitored for at least 6 hours after the last dose of naloxone.
- The use of opioid antagonists such as naloxone in people who are physically dependent on opiates can cause withdrawal symptoms.
What is Forms and Composition LAMALINE?
- Capsule (green and white): Box of 16, under blister packs. Suppository: Box of 10, under blister packs.
- Paracetamol (500 mg), dry extract of opium (15 mg) and caffeine (50 mg).
- Solid hemi-synthetic glycerides (SUPPOCIRE AML).
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