Serenace

SERENACE^®
brand of haloperidol

COMPOSITION
SERENACE 0,5 mg tablets
Each tablet contains: Haloperidol 0,5 mg.

SERENACE 1,5 mg tablets
Each tablet contains: Haloperidol 1,5 mg.

SERENACE 5 mg tablets
Each tablet contains: Haloperidol 5 mg.

SERENACE Liquid
Each 1 ml liquid contains: Haloperidol 2 mg.

SERENACE Injection
Each 1 ml ampules contains: Haloperidol 5 mg.

PHARMACOLOGY
Haloperidol acts as an anti-psychotic, depresses the central nervous system at the sub cortex of the brain, the mid brain, and the brain reticular formation, seems to inhibit the descending reticular systems of the brain stem, through the caudate nucleus, thereby interrupting the impulses between the diencephalon and the cortex. It may also inhibit the uptake of neurohumoral aminee in the mid brain. Recently it has been postulated that haloperidol acts by blocking dopaminergic neurotransmission in the central nervous system.

INDICATION
For the control of agitation, aggressiveness and hostility, hallucinations and paranoia associated with acute and chronic psychoses, mania, hipomania.
Hostile and aggressive children (the use of the drug in children only if the other psychotherapy and non-neuroleptic drugs do not take effects), Gilles de la Tourette syndrome.
For anxiety, neurosis, as an anti-emetic for radiation sickness and cancer chemotherapy.

CONTRAINDICATIONS
Serenace should not be used in patients with Parkinson's disease in severe toxic central nervous system depression or comatose states, or in patients sensitive haloperidol.

WARNINGS
Although Serenace has minimal soporific action it should be recognized that the drug can potentiate the action of central nervous system depressants, including alcohol.
Serenace should be given with great caution in patients with arteriosclerosis who may have occult lesions of the basal ganglia. Physicians Should warn patients that Serenace may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery of driving a motor vehicle.

Caution should be observed in the use of lithium salts together with high doses of Serenace, as an encephalopathy syndrome (characterized by weakness, lethargy, lever, tremulousness, confusion, extra pyramidal reactions, and elevated BUN, fasting blood sugar, and serum enzymes) has been observed.
Serenace should be discontinued in patients who experience early signs of this syndrome. Irreversible brain damage has followed the commitant use of haloperidol and lithium in few patients.
High doses of Serenace may potentiate the action of methyldopa. As with all tranquillisers. Serenace should not be use alone where psychotic depression predominates, but may be combined with antidepressants where there is associated anxiety.
Rare cases sudden and unexpected death have been reported in association with the administration of Serenace, although the nature of the evidence makes it impossible to determine the contributory role, if any, of the drug.
Two cases of fetal malformation have been reported following the maternal use of haloperidol combined with other medications. No causal relationship has been established.
The use of any drug in women of childbearing potential requires that the benefits of therapy be weighed against possible hazards to the mother and fetus. If use of Serenace during lactation is deemed necessary, an alternative method of infant feeding should be instituted. Keep this medication out of the reach of children.

PRECAUTIONS
Serenace may be given to epileptics, but adequate anti-convulsant therapy should be continued because the drug may lower the seizure threshold.
Acute dystonic reactions, including laryngeal spasm, may be relieved promptly be the intravenous or intramuscular administration of benztropine mesylate or biperiden, or intravenous diazepam. A pseudo Parkinsonian rigidity syndrome may occur during the course of treatment which may also be treated with anti Parkinsonian agents.
If symptoms and/or sign of Parkinsonism manifest themselves, the dose of Serenace should be reduced or treatment may be combined with an anti-Parkinsonian drug.
Serenace does not usually affect blood presure significantly, but care should be exercided in patients with severe cardiovascular disorders because of the possibility of transient hypotension. Epinephrine should not be used since haloperidol may block its vasopressor activity and cause a further decrease in blood pressure. As with other anti psychotic agents, Serenace has been associated with rare cases of a neuroleptic malignant syndrome in which the patient experiences fever, profound diaphoresis, autonomic dysfunction, muscular rigidity, altered consciousness, and various levels of coma. Serenace should be discontinued and symptomatic and specific treatment should be given. Serenace should be administered cautiously to patients receiving anticoagulants, since one instance of interference with the effects of phenindione has been reported.
When Serenace is used to control mania in cylic disorders, a rapid mood swing to depression may occur.

ADVERSE REACTION
Neurological effects, especially extrapyramidal syndromes, are the most common. Endocrine, dermatologic, gastrointestinal, respiratory, cardiovascular and autonomic effects have been reported. There have been reported of blood dyscrasias and impaired liver function, including jaundice. No cases of ocular opacities have occurred. Isolated cases of photosensitive skin reactions have been reported. The low incidence of photosensitive skin reactions means that rehabilitation can continue out of doors,
There have been no reports of skin reactions in nursing staff handling Serenace.
Where high dosage treatment is used, extrapyramidal side effects may be encountered at an early stage in the from of dystonic reactions or motor restlessness (akathisia). Thyrotoxic patients may be more proneto develop extrapyramidal symptoms.
As with all anti psychotic agents, Serenace may elevate serum prolactin levels. Consequently, there have been reports of galactorrhea, amenorrhea, gynecomastia and impotence.

DOSAGE AND ADMINISTRATION
Serenace is supplied in a variety of dosage forms

Oral tablets	-	0,5; 1,5; 5 mg
Liquid	-	2 mg haloperidol per 1 ml (0,1 mg per drop)
Ampules	-	5 mg haloperidol in 1 ml aqueous solution

The dosage range can vary between 1 mg and over 200 mg per day depending on the condition and the individuals response to treatment. Dosage should be titrated to clinical efficacy, then reduced to the lowest effective level. Safety of prolonged administration of high dosages has not been demonstrated by controlled clinical trials. Children and debilitated or geriatric patients may be more sensitive to haloperidol and require adjustment of the starting dose. The maximum dose and maintenance doses are generally lower for these patients.

TABLET AND LIQUID

Adults	:	Normally, treatment may be started at 0,5 - 2 mg daily for moderate symptoms or 3 - 5 mg daily for severe symptoms and increased until satisfactory control is achieved. When maximum improvements is reached, the dose should be gradually reduced to the lowest effective maintenance dose which for many patients will be 2 to 8 mg per day.
Children	:	Maintenance Dosage ; 0,05 mg/kg body weight a day. Where control is not urgent, treatment may be initialed at half the above level working up to the maintenance dosage. Serenace is not intended for children under 3 years old.
AMPULES	:
Adults	:	For rapid emergency control, 10 mg will normally be adequate. Up to 30 mg may be given by intramuscular injection. Further doses may be repeated every six hours until control is achieved. At that time, oral dosage may be substituted in diminishing doses. The intravenous route may be used if required.
Children	:	Maintenance dosage : 0.05 mg per kg body weight per day. Where control is not urgent, treatment may be initiated at half the above level working up to the maintenance dosage. In adults, therapy may be started at two or three times the maintenance dosage, and may be combined with anti-Parkinsonian drugs.

PRESENTATION :

Tablets (oral)	:	0,5 mg, green, scored, uncoated, stamped "Searle" on one side, in pack of 100 in strip packing Reg. No. DL 2012162
		1,5 mg, white, scored, uncoated, stamped "Searle" on one side, in pack of 100 in strip packing Reg. No. DL 2012163
		5 mg, red, scored, uncoated, stamped, "Searle" on one side, in pack of 100 in strip packing Reg. No. D 6016089
Liquid	:	In 15 ml and 100 ml dropper bottle which deliver 20 drops per ml containing SERENACE 2 mg per ml. Reg. No. DKL 7224209136A1
Parenteral Ampoules	:	(Amber coloured) of 1 ml containing SERENACE 5 mg in boxes of 10 Reg. No. DL 2012359.

Harus dengan resep dokter.

Manufactured in Indonesia under licence from Searle,
Division of Monsanto Australia Limited
Sydney, Australia.

Tablets, Liquid by :
PT SOHO INDUSTRI PHARMASI
JAKARTA -INDONESIA

Injections, by : PT ETHICA
JAKARTA - INDONESIA

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