Chloral Hydrate Syrup

Chloral Hydrate Syrup is used primarily as a hypnotic in the management of simple insomnia. It is effective as a hypnotic only for short term use. Chloral Hydrate Syrup has been found to lose much of its effectiveness for both inducing and maintaining sleep by the end of a 2 week period of administration. Chloral Hydrate Syrup may also be used as a routine sedative. It has been used preoperatively or prior to electroencephalographic evaluation to allay anxiety and produce sedation and/or sleep. Chloral Hydrate Syrup, alone or in conjunction with Paraldehyde, may be effective in suppressing and/or reducing alcohol withdrawal symptoms. It may also be effective in reducing anxiety associated with withdrawal of other drugs such as narcotics or barbiturates.

Chloral Hydrate Syrup is a sedative, also called a hypnotic. Chloral Hydrate Syrup slows the activity of your central nervous system. This medicine has both fast-acting and long-lasting sedative effects.

Chloral Hydrate Syrup is for short-term use as a sedative or sleep medicine. It is sometimes given before a surgery to help you relax.

Chloral Hydrate Syrup may also be used to treat alcohol withdrawal symptoms, or to relieve anxiety caused by withdrawal from certain drugs such as barbiturates or narcotic medicine.

Chloral Hydrate Syrup may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Insomnia:

500 mg to 1 g 15 to 30 minutes before bedtime.

Usual Adult Dose for Sedation:

250 mg 3 times daily after meals, or

500 mg to 1 g 30 minutes before surgery

Usual Pediatric Dose for Insomnia:

Oral, Rectal:

Hypnotic: 50 mg/kg/dose at bedtime

Maximum dose: 1 g/dose

Total maximum: 1 g/day for infants and 2 g/day for children

Usual Pediatric Dose for Sedation:

Neonatal:

Oral, Rectal:

For sedation prior to a procedure: 25 mg/kg. Repeat doses should be used with great caution as drug and metabolites accumulate with repeated use; toxicity has been reported after 3 days in a preterm neonate and after 7 days in a term neonate receiving Chloral Hydrate Syrup 40 to 50 mg/kg every 6 hours.

Infants and Children:

Oral, Rectal:

Sedation, anxiety: 25 to 50 mg/kg/day divided every 6 to 8 hours

Maximum dose: 500 mg/dose

Prior to EEG: 25 to 50 mg/kg/dose 30 to 60 minutes prior to EEG; may repeat in 30 minutes to a total maximum of 100 mg/kg or 1 g total for infants and 2 g total for children.

Sedation, nonpainful procedure: 50 to 75 mg/kg/dose 30 to 60 minutes prior to procedure; may repeat 30 minutes after initial dose if needed.

Maximum dose: 120 mg/kg or 1 g total for infants and 2 g total for children

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What is the most important information I should know about Chloral Hydrate Syrup?

Chloral Hydrate Syrup is contraindicated in patients with marked hepatic or renal impairment and in patients who have previously demonstrated hypersensitivity or an idiosyncratic reaction to the drug.

Use Chloral Hydrate Syrup syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Chloral Hydrate Syrup syrup may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Mix Chloral Hydrate Syrup syrup in half a glass of water, fruit juice, or ginger ale just before taking it. Be sure you take the entire dose.
• Take Chloral Hydrate Syrup syrup with a full glass of water or other liquid to reduce stomach upset.
• If you miss a dose of Chloral Hydrate Syrup syrup and you are taking it regularly, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Chloral Hydrate Syrup syrup.

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What other drugs will affect Chloral Hydrate Syrup?

The sedative effect of this medicine will be increased if it is taken with any of the following, which can also cause drowsiness:

* alcohol

* antipsychotics, eg chlorpromazine, haloperidol

* baclofen

* barbiturates, eg phenobarbital, amobarbital

* benzodiazepines, eg diazepam, temazepam

* MAOI antidepressants, eg phenelzine

* other sleeping tablets, eg zopiclone

* sedating antihistamines, eg chlorphenamine, hydroxyzine, promethazine

* strong opioid painkillers, eg morphine, codeine

* tricyclic and related antidepressants eg amitriptyline, maprotiline.

This medicine may increase the anti-blood-clotting effects of oral anticoagulant medicines such as warfarin. If you are taking warfarin your doctor may want to check your blood-clotting time (INR) after you start and stop treatment with this medicine.

If a furosemide injection is administered to someone who has taken this medicine, it may cause sweating, hot flushes and changes in blood pressure due to a hypermetabolic state caused by an effect on thyroid hormone.

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What are the possible side effects of Chloral Hydrate Syrup?

Gastric irritation manifested by nausea, vomiting, and diarrhea is the most frequent side effect of oral Chloral Hydrate Syrup administration. This effect may be minimized by administering the capsule with a full glass of water or other liquid. There is no evidence in the published literature to support the claim that the complex, chloral betaine, causes less gastric irritation than does Chloral Hydrate Syrup. Residual sedation or "hangover" occurs infrequently following usual hypnotic doses. Cutaneous reactions to Chloral Hydrate Syrup are not common but have included scarlatiniform or erythematous rash, urticaria, angioedema, purpura, eczema, bullous lesions, and erythema multiforme. Sometimes these cutaneous reactions have been accompanied by fever; ataxia and dizziness have also occurred. Rarely, a somnambulistic reaction characterized by disorientation and incoherence has been reported.

A hypnotic and sedative used in the treatment of insomnia. The safety margin is too narrow for Chloral Hydrate Syrup to be used as a general anesthetic in humans, but it is commonly used for that purpose in animal experiments. It is no longer considered useful as an anti-anxiety medication. [PubChem]