Drug Information

Drug Interaction:

Drug interactions -summary

Increased risk of adverse effects when used with alcohol

May potentiate the effects of general anesthetics and anticoagulants and prolong action of
neuromuscular blockers

May increase anticholinergic effects of atropine and drugs with anticholinergic activity

May increase risk of neurotoxicity when used with sibutramine or lithium

Avoid concurrent usage with drugs that cause prolongation of cardiac arrhythmias.

May inhibit metabolism of TCAs .

May antagonise effects of adrenaline and sympathomimetics and reverse antihypertensive
effects of guanithedine

Indication:

Depression

INFORMATION- UPDATE

FDC OF FLUPENTIXOL+ MELTRACEN :

PROHIBITION BY HEALTH MINISTRY RECONFIRMED

A report of the Parliamentary Committee on Health had held that the import licence

and marketing approval given by the Drug Controller General , India, (DCGI) to the

Fixed Dose Combination of Flupenthixol + Melitracen was unlawful on the following

counts:

1.Drugs and Cosmetic Rule 30-B bans imports and marketing of any drug the use of

which is prohibited in the Country of Origin. The FDC of Flupenthixol with Melitracen

is prohibited for sale and use in Denmark, its country of origin. The Committee

further noted that there must be some good reasons for Danish Drug Authority not to

approve a domestically developed drug for use within the country.

2. Since melitracen was not individually approved earlier in India , the Combination had

to undergo all phases of clinical trials(Phase I, II, and III) trial, if given by DCGI was

in violation of rules.

3. Before approving a New Drug , it is mandatory to conduct clinical trials individually

for all the different indications. A perusal of the Marketing Approval shows that the

approved indications were-

( i).Psychological depression (ii) Depressive neurosis

(iii) Masked depression (iv).Psychosomatic affections accompanied by anxiety and

apathy. The Drug Controller of India failed to give details of trials at 3-4 sites with at

least 100 patients for each indication as required by law.

4.The product was illegally being promoted for two unapproved indications

i.e. Menopausal depression , Dysphoria and depression in alcoholics and drug

addicts

5. The Committee felt that the DCGI should have gone into reasons for not marketing

the drug in major developed countries such as United States, Britain,Ireland, Canada

Japan, Australia just to mention a few

5.The Committee recommended that in view of the unlawful approval granted to the

drug, the matter should be re-examined keeping in mind the regulatory status in

well developed Countries like Denmark, the Country of Origin, the United States,

Britain, Canada, European Union and Japan etc. (Reference: 59th and 66th Reports

of the Parliamentary Committee on Health and Family Welfare http:// rajyasabha.inc.in)

6.The marketing approval of the drug was suspended on June 18,2013 by the Ministry of

Health and Family Welfare for the manufacture and sale. However, in response to

petitions filed by two manufacturers ,the Karnataka High court quashed the suspension

order on legal grounds. Without commenting on the merit of the case, the Court directed

that MoHFW should take a decison one way or the other by following legal procedure

7.The matter was referred to yet another expert Committee which meeting on August 23,2013 came to the conclusion the drug was risky and hence should be banned. Among other drawbacks, an anti-depressant melitracen when combined with antispychotic flupentixole carried additional risks

8.The decision to ban the drug was reconfirmed by the Drugs Technical Advisory Board

in its meeting held on November 25,2013.

(MIMS- FEB.2014)

Adverse Reaction:

Drowsiness, dry mouth, constipation, vomiting, dyspepsia,
Diarrhoea, abdominal pain, nausea, flatulance

Extrapyrimidal effects, espeicially in the initial phase of treatment.
Tachycardia, palpitations, prolonged QT interval, hypotension

Thrombocytopenia, neutropenia, leukopenia, aganulocytosis,
Dyspnoea, myalgia, muscle rigidity, micturation disorder,

Urinary retension, increased appetite and weight,
Abnormal glucose tolerance, and LFTs,

Insomnia, depression, nervousness, agitation, libido decreased.

Contra-Indications:

Circulatory collapse, depressed level of consciouness due to any cause, comasevere depression requiring hospitalisation or electroconvulsive therapy

not recommended for use in states of excitement or overactivity

Special Precautions-
unsafe in porphyia

caution when used in patients with epilepsy.

Parkinsons disease narrow angle glaucoma, prostrate hypertropthy,
hyperthyroidism, liver disease, cardiac disease, or arrhythmias,

severe respiratory disease, renal failure,
myasthenia gravis,

patients with hypersensitivity to antipsychotics,
close monitoring for changes in behaviour, sucidal thoughts,or
clinical worsening during initial phase of treatment

may impair control of diabetes, monitor blood glucose in diabetes
withdrawal should be gradual

Dosages/ Overdosage Etc:

Indication-

Depression

Dosage-
Adult- 1 tablet in the morning and 1 tablet at mid day.
May double morning dose in severe cases.
Not to exceed 4 tablets daily

Elderly- 1 tablet in the morning and 1 at mid day.

Flupentixol + Melitracen - Anti-depressants

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Drug Interaction:

Indication:

Adverse Reaction:

Contra-Indications:

Dosages/ Overdosage Etc:

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