Medicinal Products

ANAFRANIL 25 mg / 2 mL Solution for injection (IM, IV) Box of 5 ampoules of 2 ml

Generic drug of the therapeutic class: Analgesics
Active ingredients: Clomipramine
laboratory: Sigma Tau France

Solution for injection (IM, IV)
All forms

Indication

- Major depressive episodes (that is, characterized).
- Obsessive compulsive disorders.
- Neuropathic pain of the adult.

Dosage ANAFRANIL 25 mg / 2 mL Solution for injection (IM, IV) Box of 5 ampoules of 2 ml

DEPRESSION AND OBSESSIVE COMPULSIVE DISORDERS OF ADULT :
- Dosage and method of administration :
The attack treatment is initiated in hospital (for IV) until improvement.
. IM Way:
Start the treatment in progressive doses for one week, to reach a dosage of 4 to 6 ampoules per day (100 to 150 mg per day).
The improvement once obtained, gradually replace each ampoule with two tablets dosed at 25 mg (equivalent dose).
. IV infusion:
Administer as slow intravenous infusion (2 hours 30 to 3 hours) 2 to 3 ampoules diluted in 250 ml of isotonic saline.
Leave the patient bedridden for about one hour after the end of the infusion.
. Once the improvement is obtained, relay the infusions by oral route at bioequivalent doses, two 25 mg tablets instead of a blister.
- Duration of treatment :
Antidepressant treatment is symptomatic.
The treatment of an episode is several months (usually about 6 months) to prevent the risk of relapse of the depressive episode.
NEUROPATHIC PAIN OF ADULT :
- The treatment must be initiated in hospital for the IV route.
Administer as a slow intravenous infusion (2 hours 30 to 3 hours) 1/2 to 1 ampoule diluted in 100 ml of isotonic saline.
Leave the patient bedridden for about one hour after the end of the infusion.
- Treatment should start at low doses for one week. The dose is then gradually increased in increments of 10 to 25 mg every week, depending on the tolerance.
The dosage is individual (from 10 to 75 mg of solution per day), and must take into account any associated analgesic treatments.
Once the improvement is obtained, gradually replace each ampoule with a bioequivalent dose in tablets, that is 2 25 mg tablets for one ampoule.
Maintenance treatment should be at the lowest effective dose, and the benefit of treatment should be reevaluated periodically.
OBSESSIVE COMPULSIVE DISORDERS OF THE CHILD AND THE ADOLESCENT :
Child and teenager.
Limited data exists from short-term clinical trials in children over 10 years of age and adolescents. The initial dose of 25 mg per day will be gradually increased if necessary depending on the tolerance. The maximum daily dosage is 3 mg / kg / day. The dosage may not exceed 100 mg / day during the first 2 weeks and 200 mg / day thereafter.
The interest of the treatment will have to be reevaluated periodically.
RISK POPULATIONS :
- Elderly:
The ability to metabolize and eliminate drugs may be reduced, leading to a risk of increased plasma levels at therapeutic doses. Treatment will be initiated at a low dosage, that is, in practice at half the recommended minimum dosage (see pharmacokinetic properties). The increase in doses, if necessary, will be gradual, with clinical surveillance: the adverse effects of imipramines (in particular anticholinergic, neurological and psychiatric effects) can have serious consequences for the elderly (falls, confusion).
- Hepatic and renal impairment:
The dosage should be reduced (see section 5.2).

Against indications

CONTRAINDICATED:
This medicine MUST NEVER BE prescribed in the following cases:
- hypersensitivity to clomipramine or any of its excipients,
- known risk of glaucoma by closing the angle,
- risk of urinary retention related to urethroprostatic disorders,
- recent myocardial infarction,
- combination with non-selective MAOIs (iproniazide, nialamide) and sultopride (neuroleptic benzamide) (see section on interactions).
NOT RECOMMENDED :
- Breast-feeding: The passage into breast milk is poorly known but probably weak; however, as a precaution, breastfeeding should be avoided during the course of treatment.
- Associations advised against : alcohol; clonidine, guanfacine; MAOI selective A (moclobemide, toloxatone); alpha and beta sympathomimetics (adrenaline, norepinephrine, dopamine for parenteral systemic action); linezolid.

Adverse effects Anafranil

It can be difficult to distinguish certain side effects from certain symptoms of depression such as asthenia, sleep disorders, agitation, anxiety, constipation and dryness of the mouth, the appearance of manic episodes or hypomanic.

Frequency estimate: very common: ≥ 10%; frequent: ≥1% - <10%; uncommon: ≥ 0.1% - <1%; rare: ≥ 0.01% - 0.1%; very rare: <0.01%.

General events

Very common : asthenia often associated with other side effects of clomipramine.

Very rare : fever sometimes in the context of a serotonin syndrome or malignant syndrome.

Psychiatric effects

Very common : drowsiness.

Common : confusion, agitation (sometimes as part of a serotonin syndrome or malignant syndrome), delusions, memory problems, insomnia.

Cases of suicidal ideation and behavior have been reported during treatment with ANAFRANIL or shortly after discontinuation (see Warnings and Precautions section ).

Cases of aggression have been reported occasionally.

Neurological and muscular effects

Very common : vertigo, tremors, myoclonus.

Frequent : headache, paresthesia.

Uncommon : convulsions (whose risk of occurrence increases with the dosage and especially above 250 mg per day), ataxia.

Very rare : subclinical modification of encephalographic frequencies.

Cases of dysarthria and syncope have been reported.

Hypertonic and muscular hypotonia, sometimes in the context of serotonin syndrome or malignant syndrome, have been reported.

Akathisias have been reported.

Anticholinergic effects

Very common : dry mouth, constipation, blurred vision, accommodation disturbance, urination disorder.

Frequent : hot flashes, sweat, mydriasis.

Very rare : glaucoma, urinary retention.

Cardiovascular disorders

Very common : orthostatic hypotension.

Frequent : tachycardia, palpitation (see Warnings and Precautions section ).

Very rare : disorders of conduction or rhythm, cardiomyopathy.

Gastrointestinal disorders

Very common : nausea.

Common : vomiting, abdominal pain, anorexia.

Liver effects

Frequent : asymptomatic elevation of liver enzymes.

Very rare : cholestatic or cytolytic hepatitis.

Skin effects

Common : skin reactions including urticaria, maculopapular rash, vasculitis and pruritus.

Rare : photosensitivity reaction that may cause skin pigmentation.

Very rare : alopecia.

Injection site reactions have been reported.

Endocrine disorders

Very common : weight gain, libido disorder, impotence.

Rare : galactorrhea, breast hypertrophy.

Very rare : syndrome of inappropriate secretion of anti-diuretic hormone, peripheral edema.

Pulmonary manifestations

Very rare : infiltrating pneumopathy.

Hypersensitivity reaction

Very rare : anaphylactic or anaphylactoid reaction.

Hematological effects

Very rare : leukopenia, agranulocytosis, thrombocytopenia and thrombocytopenic purpura, eosinophilia.

Organs of the senses

Common : taste alteration, tinnitus

Other

· Withdrawal reaction with the following side effects: nausea, vomiting, abdominal pain, insomnia, headache, nervousness, anxiety, frequently occur upon abrupt cessation of treatment or reduction of dosage.

· Serotonin syndrome, exceptionally monotherapy, most commonly described in case of drug interaction or overdose (see sections Interactions with other drugs and other forms of interaction and Overdose ).

· Class effect:
Epidemiological studies, mainly in patients aged 50 years and older, show an increased risk of bone fractures in patients receiving selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants. The mechanism leading to this risk is unknown.

Some of these side effects can be prevented or prevented by adjuvant or corrective therapies, or even reduction of the dosage.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. www.ansm.sante.fr.

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