temgesic 0.2 mg sublingual tablet Uses, Dosage, Side Effects, Precautions & Warnings

temgesic 0.2 mg sublingual tablet  >> Generic drug of the Therapeutic class: Analgesics
active ingredients: Buprenorphine

what is temgesic 0.2 mg sublingual tablet ?

This medication is an analgesic (it relieves pain).

what is temgesic medication used for and indication?

This medication is recommended for severe pain, in particular that which is resistant to other analgesic drugs (for example following certain surgical procedures).

PRESENTATION (S) AVAILABLE FOR TEMGESIC 0.2 MG

8 presentations are available for this drug:

• High density polyethylene (HDPE) bottle (s) of 20 tablet (s)
• High density polyethylene (HDPE) bottle (s) of 30 tablet (s)
• High density polyethylene (HDPE) bottle (s) of 50 tablet (s)
• High density polyethylene (HDPE) bottle (s) of 100 tablet (s)
• nylon aluminum uPVC blister pack (s) of 20 tablet (s)
• nylon aluminum uPVC blister pack (s) of 30 tablet (s)
• nylon aluminum uPVC blister pack (s) of 50 tablet (s)
• nylon aluminum uPVC blister pack (s) of 100 tablet (s)

FEATURE	DESCRIPTION
Pharmaceutical class	pain relievers
Active substance (s)	for one tablet: buprenorphine (hydrochloride) (0.216 mg)
General medicine	no
Pharmaceutical form	compressed
Route (s) of administration	sublingual
Social security reimbursement rate	65%
Laboratory (s)	RB PHARMACEUTICALS FRANCE
Conditions of issue	available by simple prescription

temgesic Dosage

• The dosage should be adjusted according to the intensity of the pain.
• In adults: 1 to 2 tablets per dose, on average 3 times per day.
• In subjects over 65 years of age and in particular over 80 years: the dosage should be reduced by half.
• For older children aged 7 to 15: 1 to 2 tablets per 24 hours, depending on weight, under careful medical supervision.
• STRICTLY COMPLY WITH THE MEDICAL PRESCRIPTION.

temgesic Contraindications

Never use TEMGESIC 0.2 mg sublingual tablet in the following cases:

• known allergy to buprenorphine or to any of the ingredients of this medication,
• children under 7,
• severe respiratory failure,
• severe liver disease,
• acute alcohol poisoning and alcohol withdrawal syndrome (delirium tremens),
• treatment with other morphine analgesics.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

How do you take Temgesic?

Method and route of administration

• Sublingual route.
• The tablets should not be swallowed or chewed: place them under the tongue and allow them to dissolve slowly.

Frequency of administration

• STRICTLY COMPLY WITH THE MEDICAL PRESCRIPTION.

Duration of treatment

• STRICTLY COMPLY WITH THE MEDICAL PRESCRIPTION.

how does temgesic work?

• After sublingual administration of 0.4 mg of buprenorphine, the drug is dosed in plasma from the 30 ^th minute and the peak plasma concentration is reached within 2 to 3 hours.
• The absolute bioavailability is of the order of 75%.
• The biotransformation of buprenorphine takes place in the liver where it undergoes N-dealkylation and glucuronoconjugation.
• Excretion of buprenorphine occurs primarily in the bile and stool.

How To Store temgesic ?

• Keep this medication out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister, EXP. The expiration date refers to the last day of that month.
• Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

temgesic Side Effects

Like all medicines, TEMGESIC 0.2 mg sublingual tablets can cause side effects, although not everybody gets them.

The following side effects have been observed:

• Common side effects (1% -10%): constipation, nausea, vomiting, insomnia, headache, malaise and dizziness, fatigue, drowsiness, drop in blood pressure when changing from lying or sitting to lying down or sitting down standing, sweating.
• Rare side effects (0.01% -0.1%): respiratory failure, hallucinations, hepatitis (liver damage) with jaundice.
• Other reported side effects: hypersensitivity reactions (allergy), such as rash, pruritus (itching), bronchospasm (bronchial spasm), angioedema (swelling of the face and neck which may cause breathing difficulties) and anaphylactic shock ( severe generalized allergic reaction).

If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

temgesic Interactions

Contraindicated associations

Level III morphine agonists ( alfentanil, dextromoramide, fentanyl, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanyl, sufentanil )

• Decrease in the analgesic effect by competitive blocking of receptors, with the risk of the appearance of a withdrawal syndrome.

Not recommended associations

Other morphine analgesics

• Decrease in the analgesic effect by blocking the receptors with the risk of the appearance of a withdrawal syndrome.

Alcohol

• Alcohol enhancement of the sedative effect of buprenorphine; impaired alertness can make driving and using machines dangerous.
• Avoid taking alcoholic drinks and drugs containing alcohol.

Associations to take into account

Benzodiazepines

• Increased risk of respiratory depression, which may be fatal in case of overdose.

Other sedative drugs:

morphine derivatives (analgesics, cough suppressants and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (eg meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepine, mirtiprazine, mirtazamine, ), sedative H 1 antihistamines , central antihypertensive drugs, baclofen and thalidomide:

Increase in central depression. Impaired vigilance can make driving and using machines dangerous.

Combinations subject to precautions for use

CYP3A4 inhibitors ( amprenavir and by extrapolation fosamprenavir, alazanavir, itraconazole, ketoconazole, nelfinavir, ritonavir )

• Increase in buprenorphine concentrations due to a decrease in its hepatic metabolism, with the risk of an increase in its adverse effects. Clinical monitoring and dosage adjustment of buprenorphine during treatment with the protease inhibitor and, if necessary, after its discontinuation.

Effects on ability to Drive and use machines

Attention is drawn, especially among vehicle drivers and users of machines, to the risk of drowsiness associated with the use of this medication.

Warnings and Precautions

Special warnings

• This medicine can cause psychological and physical dependence during prolonged treatment.
• This drug can cause drowsiness which may be increased by products such as alcoholic drinks, tranquilizers, sedative drugs, sleeping pills.
• This medicine contains lactose. Its use is not recommended in patients with lactose intolerance (a rare hereditary disease).

Precautions for use

• In case of surgery, tell the anesthesiologist to take this medication.
• IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

• Clinically, there is currently no sufficiently relevant data to assess a possible malformative or fetotoxic effect of buprenorphine when it is administered during pregnancy.
• However, given the expected benefit to the mother, buprenorphine may be prescribed during pregnancy.
• During the last three months of pregnancy, chronic use of buprenorphine by the mother, regardless of the dose, can cause withdrawal syndrome in the newborn.
• In addition, at the end of pregnancy, high doses of buprenorphine, even in brief treatment, are liable to cause respiratory depression in the newborn.
• Consequently, at the end of pregnancy in the event of occasional high doses or chronic administration of buprenorphine, neonatal monitoring should be considered because of a theoretical risk of respiratory depression or withdrawal syndrome in the newborn. .

Feeding with milk

• Due to the passage of buprenorphine and its metabolites in breast milk and insufficient clinical data, it is preferable as a precaution to avoid breast-feeding in case of maternal treatment.

What happens if I overdose from temgesic ?

• Despite a large safety margin, overdose can occur with high dosages.
• In the event of accidental overdose, comprehensive management should be instituted, including close monitoring of the patient’s respiratory and cardiac status. The main symptom to be treated is respiratory depression, which can lead to respiratory arrest and death. If the patient vomits, precautions should be taken to avoid bronchial inhalation of digestive contents.

Treatment :

• Symptomatic treatment of respiratory depression by appropriate means should be initiated. Freedom of the upper airways should be ensured as well as controlled ventilation, or assisted if necessary. The use of an opioid antagonist (naloxone) is recommended, despite its modest effect on the respiratory symptoms due to buprenorphine, the latter being strongly bound to the morphine receptors. Doxapram can also be used.
• Postoperatively, one of the components of respiratory depression may be the residual effect of previously administered narcotics, so naloxone should be given as a first-line treatment, then the use of doxapram may be considered.
• In the event of administration of an opioid antagonist (naloxone), the long duration of action of the product should be taken into account.

What should I do if I miss a dose?

• Ask the prescribing doctor for his opinion.

What happens if you stop taking temgesic ?

• Abrupt discontinuation of treatment may lead to the appearance of a withdrawal syndrome.
• If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

What is  Forms and Composition ?

Appearance and shape

• White tablet.
• 20 tablets in blister packs (Nylon / Aluminum / uPVC).

Other shapes

• TEMGESIC 0.3 mg / ml, solution for injection, box of 2 ampoules of 1 ml
• TEMGESIC 0.3 mg / ml, solution for injection, box of 10 ampoules of 1 ml
• TEMGESIC 0.2 mg, sublingual tablet, box of 50

Composition

Active ingredient Sublingual tablet

Buprenorphine 0.2 mg * * per unit dose

Active ingredients: Buprenorphine

Excipients with known effects ? : Lactose

Other excipients:

Mannitol, Corn starch, Polyvidone excipient, Citric acid, Magnesium stearate, Sodium citrate

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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