clemastine

REMS

Relief of allergic symptoms caused by histamine release including:
- Allergic rhinitis,
- Urticaria.

Contraindicated in:

Hypersensitivity;
Angle-closure glaucoma;
Known alcohol intolerance (liquid form);
Lactation: Lactation.

Use Cautiously in:

Acute asthma attacks;
Liver disease;
Prostatic hyperplasia;
Hyperthyroidism;
Hypertension;
OB: 2nd-generation antihistamines are preferred in pregnancy;
Pedi: Children <6 yr (safety and effectiveness not established);
Geri: Older adults are more susceptible to adverse reactions.

CV: hypertension, arrhythmias, hypotension, palpitations, tachycardia

Derm: rash

EENT: blurred vision

GI: dry mouth, constipation, GI obstruction, nausea, vomiting

GU: urinary retention

Neuro: drowsiness, confusion, dizziness, paradoxical excitation (children)

Resp: thick mucus

Drug-drug:

Additive CNS depression with other CNS depressants, including alcohol, opioid analgesics, and sedative/hypnotics.
May antagonize effects of cholinergic agonists (e.g. donepezil).

Drug-Natural Products:

Kava-kava, valerian, skullcap, chamomile, or hops can ↑ risk of CNS depression.

(Generic available)

Tablets: 2.68 mg (2 mg base)
Syrupcitrus flavor: 0.67 mg/5 mL (0.67 mg clemastine fumarate = 0.5 mg base) (contains 5.5% alcohol)

PO (Adults ): OTC labeling: 1.34 mg (1 mg base) twice daily. Rx labeling: 1.34 mg (1 mg base) twice daily; may ↑ up to 2.68 mg (2 mg base) 3 times daily.
PO (Children 6–12 yr): 0.67–1.34 mg (0.5–1 mg base) twice daily (not to exceed 4.02 mg/day (3 mg/day base).

Antagonizes the effects of histamine at H₁-receptor sites; does not bind to or inactivate histamine.

Therapeutic effects:

Decreased symptoms of histamine excess (sneezing, rhinorrhea, nasal and ocular pruritus, ocular tearing, and redness).

Therapeutic Classification: allergy, cold and cough remedies, antihistamines

Absorption: Well absorbed following oral administration.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Extensively metabolized by the liver.

Half-Life: 21 hr.

(antihistaminic effects)

ROUTE	ONSET	PEAK	DURATION
PO	15–60 min	1–2 hr	8–16 hr

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Instruct patient not to take more than recommended amount. Take missed doses as soon as possible unless almost time for next dose.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Caution patient to avoid using alcohol or other CNS depressants, including opioids, concurrently with this drug.
May cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to drug is known.
Advise patient that good oral hygiene, frequent rinsing of mouth with water, and sugarless gum or candy may help relieve dry mouth. Patient should notify dentist if dry mouth persists for >2 wk.
Caution patient of risk for orthostatic hypotension and to change positions slowly, especially older adults.
Instruct patient to notify health care professional of difficulty with urination, change in vision, confusion, severe dry mucous membranes, or dizziness.
Advise parent or caretaker of risk for paradoxical reaction in children and to notify health care professional if the child has difficulty sleeping, becomes unusually excited or irritable, or develops shortness of breath or facial flushing.
Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid use during breastfeeding.

NDC Code

0093- Teva Pharmaceuticals USA, Inc.
- 0093-0308- Clemastine Fumarate
  - 0093-0308-01- 100 TABLET in 1 BOTTLE (0093-0308-01)

55152- Sekisui Medical Co., Ltd.
- 55152-001-
  - 55152-001-01- 500 g in 1 CAN (55152-001-01)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  - 58159-123-01- 35 kg in 1 DRUM (58159-123-01)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  - 58159-123-02- 25 kg in 1 DRUM (58159-123-02)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  58159-123-03- 20 kg in 1 DRUM (58159-123-03)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  58159-123-04- 15 kg in 1 DRUM (58159-123-04)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  58159-123-05- 10 kg in 1 DRUM (58159-123-05)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  58159-123-06- 5 kg in 1 DRUM (58159-123-06)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  58159-123-07- 2 kg in 1 DRUM (58159-123-07)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  58159-123-08- 1 kg in 1 DRUM (58159-123-08)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  58159-123-09- .5 kg in 1 DRUM (58159-123-09)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  58159-123-10- .1 kg in 1 DRUM (58159-123-10)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  58159-123-11- .01 kg in 1 DRUM (58159-123-11)

58159- NURAY CHEMICALS PRIVATE LIMITED
- 58159-123-
  58159-123-12- .001 kg in 1 DRUM (58159-123-12)

62135- Chartwell RX, LLC
- 62135-713- CLEMASTINE FUMARATE
  62135-713-41- 120 mL in 1 BOTTLE (62135-713-41)

64950- Genus Lifesciences
- 64950-268- Clemastine Fumarate
  - 64950-268-03- 30 TABLET in 1 BOTTLE (64950-268-03)

64950- Genus Lifesciences
- 64950-268- Clemastine Fumarate
  - 64950-268-10- 100 TABLET in 1 BOTTLE (64950-268-10)

64950- Genus Lifesciences
- 64950-324- Clemastine Fumarate
  - 64950-324-12- 120 mL in 1 BOTTLE (64950-324-12)

71085- IPG Pharmaceuticals, Inc.
- 71085-081- CLEMSZA
  - 71085-081-30- 30 TABLET in 1 BOTTLE (71085-081-30)

73377- AX Pharmaceutical Corp
- 73377-061-
  - 73377-061-01- 25 g in 1 JAR (73377-061-01)

73377- AX Pharmaceutical Corp
- 73377-061-
  73377-061-02- 5 g in 1 JAR (73377-061-02)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-01- 35 kg in 1 DRUM (83511-016-01)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-02- 25 kg in 1 DRUM (83511-016-02)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-03- 20 kg in 1 DRUM (83511-016-03)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-04- 15 kg in 1 DRUM (83511-016-04)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-05- 10 kg in 1 DRUM (83511-016-05)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-06- 5 kg in 1 DRUM (83511-016-06)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-07- 2 kg in 1 DRUM (83511-016-07)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-08- 1 kg in 1 DRUM (83511-016-08)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-09- .5 kg in 1 DRUM (83511-016-09)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-10- .1 kg in 1 DRUM (83511-016-10)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-11- .01 kg in 1 DRUM (83511-016-11)

83511- STHREE CHEMICALS PRIVATE LIMITED
- 83511-016-
  83511-016-12- .001 kg in 1 DRUM (83511-016-12)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆