Adult Dosing
Allergic conditions
- 6.25-12.5 mg PR tid; alt 25 mg at bed time, after initiation of therapy adjust doses to lowest effective dose
Nausea/vomiting
- 12.5-25 mg PR q4-6 hrs. [MAX: 50 mg/dose]
Prophylaxis of nausea and vomiting
- Repeat 25 mg PR at q4-6hr intervals
Motion sickness
- 25 mg PR 30-60 mins prior to departure, then q 8-12 hrs PRN, on succeeding days of travel 25 mg in morning and before evening meal
Sedation
- 25-50 mg PR X 1 [MAX: 50 mg/dose]
Pre- and Postoperative Use
- 50 mg PR at night before surgery
Preoperative medication
- 50mg PR with reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug
Postoperative sedation
- Use with analgesics, 25-50mg PR
Pediatric Dosing
- Safety and effectiveness in pediatric patients <2yrs of age have not been established
Allergic conditions
- >2 yrs: 6.25-12.5 mg PR tid; alt 25 mg at bed time, after initiation of therapy adjust doses to lowest effective dose
Nausea/vomiting
- >2 yrs: 0.25-1 mg/Kg/dose PR q4-6 hrs PRN. [MAX: 25 mg/dose]
Prophylaxis of nausea and vomiting
- Repeat 25 mg PR at q4-6hr intervals
Motion sickness
- >2 yrs: 0.5 mg/kg PR 30-60 mins prior to departure, then q12 hrs PRN. [MAX: 25 mg/dose]
Sedation
- >2 yrs: 12.5-25 mg PR X 1 [MAX: 25 mg/dose]
Pre- and Postoperative Use
- 12.5-25 mg at night before surgery
Preoperative medication
- 0.5 mg /pound of body weight with reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug
Postoperative sedation
- Use with analgesics, 12.5-25mg PR
[Outline]
See Supplemental Patient Information
- Contraindicated in pediatric patients with <2 yrs as fatal respiratory depression have occurred, respiratory depression have occurred due to wide-range of weight based doses in these patients, administer drug with caution in pediatric patients
2 yrs [US Black Box Warning] - Use lowest effective dose in pediatric patients 2 yrs and avoid concomitant use with other respiratory depressant drugs [US Black Box Warning]
- Avoid concurrent use of central-nervous-system depressants such as alcohol, sedative, hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers or reduce doses of such drugs when used with promethazine
- Avoid use in patients with compromised respiratory function or having risk for respiratory failure as fatal respiratory depression have occurred
- Lowers seizure threshold, avoid concomitant medications, such as narcotics or local anesthetics as they may also affect seizure threshold
- Results in bone marrow depression, leukopenia and agranulocytosis have occurred when used in association with other known marrow-toxic agents
- Fatal neuroleptic malignant syndrome (NMS) have occurred in association with promethazine alone or in combination with antipsychotic drugs
- Carefully diagnose patients for serious medical illness (e.g. pneumonia, systemic infection, etc.) ,untreated or inadequately treated extrapyramidal signs and symptoms, central anticholinergic toxicity, heart stroke, drug fever, and primary central nervous system pathology
- Immediately discontinue antipsychotic drugs and other drugs not essential for concomitant therapy, provide intensive symptomatic treatment, carefully monitor patients and provide treatment for concomitant serious medical problems for management of NMS
- Carefully consider potential reintroduction of drug therapy in patients recovered from NMS as recurrences of NMS can occur
- Respiratory depression, apnea and fatal death not directly associated with wide-range of weight based doses but associated with promethazine products have occurred
- Hyperexcitability and abnormal movements have been reported in pediatric patients following a single administration of promethazine; discontinue promethazine and the use of other drugs should be considered
- Avoid use of antiemetic drugs in pediatrics for unknown etiology and reserve only for prolonged vomiting
- Extrapyramidal symptoms have occurred, avoid use in pediatrics showing signs and symptoms of reye’s syndrome or other hepatic diseases
- Excessively higher dosages may cause sudden death
- Acutely ill pediatric patients with associated dehydration are susceptible to dystonias
- Cholestatic jaundice have occurred on administration
- False-negative or false positive interpretations are possible during diagnosing pregnancy tests based on immunological reactions between HCG and anti-HCG
- Increase in blood glucose have occurred
Caution: Use cautiously in
- Hepatic impairment
- Cardiovascular disease
- COPD
- Asthma
- Seizure disorders
- Lowered seizure threshold
- Bone-marrow depression
- Narrow angle glaucoma
- Prostatic hypertrophy
- Stenosing peptic ulcer
- Pyloroduodenal obstruction
- GI obstruction
- GU obstruction
- Bladder neck obstruction
- IV administration
- Hypersensitivity to sulfites
- Use of CNS depressant
- Pediatric
- Geriatric
Supplemental Patient Information
- Instruct patients to operate hazardous machinery, automobiles and engage in activities requiring mental alertness carefully
- Avoid prolonged exposure to the sun
- Advise patients to report any involuntary muscle movements
Pregnancy Category:C
Breastfeeding: Possibly unsafe; however occasional short term use of promethazine would pose little risk to the breastfed infant. It may interfere with lactation if given in the early postpartum period. Other less potent antihistamines are preferred. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 November 2010). Manufacturer recommends discontinuation of breastfeeding or treatment taking into accounts the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Promethegan 25 MG SUPP [Box] (G & W LABS)
12 mg = $58.99
36 mg = $165.98 - Promethazine HCl 12.5 MG SUPP [Box] (PERRIGO PHARMACEUTICALS)
12 mg = $49.99
36 mg = $135.97 - Promethegan 12.5 MG SUPP [Box] (G & W LABS)
12 mg = $25.99
36 mg = $69.98 - Promethegan 50 MG SUPP [Box] (G & W LABS)
12 mg = $107.99
36 mg = $323.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
