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brompheniramine/phenylephrine (Brovex PB, Respahist-II, Vazotab Chewable, Children's Dimetapp Cold and Allergy)

 

Classes: Antihistamine/Decongestant Combos

Dosing and uses of Brovex PB, Respahist-II (brompheniramine/phenylephrine)

 

Adult dosage forms and strengths

brompheniramine/phenylephrine

tablet, chewable

  • 6mg/15mg

capsule, extended-release

  • 6mg/7.5mg
  • 12mg/15mg

oral suspension

  • (6mg/10mg)/5mL
  • (4mg/10mg)/5mL

oral solution

  • (1mg/2.5mg)/5mL
  • (2mg/5mg)/5mL

oral drops

  • (0.4mg/1mg)/1mL

tablet, sustained-release

  • 6mg/18mg
  • 6mg/7.5mg

tablet

  • 4mg/10mg
  • 6mg/30mg
  • 4mg/10mg

 

Congestion

Sustained/Extended release products: 1-2 tablets PO q8-12hr PRN, not to exceed recommended maximum dosage

Tablets: 1-2 tablets PO q4-6hr PRN, not to exceed recommended maximum dosage

Liquids: 5-10 mL PO q4-6hr PRN, not to exceed recommended maximum dosage

Recommended maximum dosages

  • Brompheniramine: 24 mg PO in 24 hr
  • Phenylephrine: 60 mg PO in 24 hr

 

Other Information

Refer to manufacturer information for dosing details; multiple strengths available

Administer liquids with special measuring device for accurate dose

 

Pediatric dosage forms and strengths

brompheniramine/phenylephrine

tablet, chewable

  • 1mg/2.5mg
  • 6mg/15mg

capsule, extended-release

  • 6mg/7.5mg
  • 12mg/15mg

oral suspension

  • (6mg/10mg)/5mL
  • (4mg/10mg)/5mL

oral solution

  • (1mg/2.5mg)/5mL
  • (2mg/5mg)/5mL

oral drops

  • (0.4mg/1mg)/1mL

tablet, sustained-release

  • 6mg/18mg
  • 6mg/7.5mg

tablet

  • 4mg/10mg
  • 6mg/30mg
  • 4mg/10mg

 

Congestion

Refer to manufacturer information for dosing details; multiple strengths available

Do not exceed recommended maximum dosages

Recommended maximum dosages

  • Neonates: Do not use
  • Infants: Must individualize dosage, under health care professional direction
  • 12-24 months: Must individualize dosage, under health care professional direction
  • 2-6 years: 6 mg/15 mg PO in 24 hr
  • 6-12 years: 12 mg/30 mg PO in 24 hr
  • >12 years: 24 mg/60 mg PO in 24 hr

 

Brovex PB, Respahist-II (brompheniramine/phenylephrine) adverse (side) effects

Phenylephrine

Brompheniramine (Common)

  • Anticholinergic effects (blurred vision, dry mouth/nose, throat)
  • Drowsiness, dizziness, decreased coordination, headache
  • Constipation, stomach upset

Phenylephrine (Common)

  • Hypertension, reflex bradycardia
  • Anxiety, dizziness, excitability, headache, nervousness, restlessness
  • Rebound congestion, sneezing, pulmonary edema

 

Warnings

Contraindications

Phenylephrine

  • Hypersensitivity to phenylephrine or sulfites; severe HTN, VTach, closed angle glaucoma
  • See Interactions below

 

Cautions

Phenylephrine

  • Cerebrovascular insufficiency, CVD, HTN, DM, thyroid dz, prostatic hypertrophy, geriatrics

 

Pregnancy and lactation

Pregnancy category: C; not recommended in first tri-mester or last 2 weeks of pregnancy

Lactation: Contraindicated

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Brovex PB, Respahist-II (brompheniramine/phenylephrine)

Mechanism of action

Brompheniramine: Histamine H1-receptor antagonist; elicits high antihistamine activity, low sedative effects, and moderate anticholinergic effects

Phenylephrine: Strong alpha effects resulting in increased PVR and BP and decreased CO and renal perfusion

 

Absorption

Onset: 15-30 min

Duration: 3-9 hr, may last 48 hr (brompheniramine); 2-4 hr (phenylephrine)

Peak Plasma Time: 2-5 hr (brompheniramine)

 

Distribution

Vd: 11.7 L/kg (brompheniramine)

 

Metabolism

Brompheniramine: Mainly liver; metabolites include propionic acid derivative conjugated with glycine

Phenylephrine: Liver and intestine by MAO

 

Elimination

Half-Life: 11.8-34.7 hr (brompheniramine)

Excretion: Urine