levodopa

REMS

Intermittent treatment of "off" episodes in patients with Parkinson’s disease treated with carbidopa/levodopa.

Contraindicated in:

Concurrent or recent (within past 2 wk) use of nonselective MAO inhibitor therapy;
Major psychotic disorders;
Asthma, COPD, or underlying lung disease (may ↑ risk of bronchospasm).

Use Cautiously in:

Glaucoma (may ↑ intraocular pressure);
OB: Safety not established;
Lactation: Use while breast feeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established;
Geri: ↑risk of adverse reactions.

CV: orthostatic hypotension

EENT: ↑intraocular pressure, nasal discharge discoloration, nasopharyngitis

GI: ↑liver enzymes, hyperbilirubinemia, nausea, vomiting

MS: dyskinesias

Neuro: aggression, agitation, confusion, delirium, delusions, disorientation, hallucinations, headache, insomnia, paranoid ideation, psychosis, sedation, urges (gambling, sexual), vivid dreams

Resp: cough, sputum discoloration, upper respiratory tract infection

Misc: falls

Drug-drug:

Nonselective MAO inhibitors, including phenelzine or tranylcypromine, can ↑ risk of severe hypertension; concurrent use contraindicated (MAO inhibitor must be discontinued ≥2 wk before initiating levodopa).
Selective MAO inhibitors, including rasagiline or selegiline may ↑ risk of orthostatic hypotension.
Haloperidol, isoniazidmetoclopramide, phenothiazines, or risperidone may ↓ effectiveness.
Iron or multivitamins containing iron may ↓ absorption of levodopa.

Capsules for oral inhalation: 42 mg

Should be used in patients already taking carbidopa/levodopa.
Inhaln (Adults ): 84 mg as needed for "off" episodes up to 5 times per day (max = 420 mg/day).

Converted to dopamine in the CNS, where it serves as a neurotransmitter.

Therapeutic effects:

Reduction in "off" episodes.

Therapeutic Classification: antiparkinson agents

Pharmacologic Classification: dopamine agonists

Absorption: 70% absorbed following oral inhalation.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Primarily metabolized in liver by decarboxylation (via dopa decarboxylase) and O-methylation (by catechol-O-methyltransferase [COMT]).

Half-Life: 2.3 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
Inhaln	unknown	30 min	unknown

Instruct patient to take medication when their Parkinson’s symptoms (OFF periods) first occurs as directed. Instruct patient in correct use of Imbrija inhaler and that each dose is 2 capsules. Capsules are for use in inhaler; do not take orally. Discontinue slowly; abrupt discontinuation may cause fever, confusion, stiff muscles, changes in breathing and heartbeat. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
May cause sudden onset of sleep, drowsiness, or dizziness. Advise patient to avoid driving and other activities that require alertness until response to drug is known.
Inform patient that medication may cause dark color bodily fluids (saliva, sputum, urine, sweat).
Advise patient to notify health care professional if abnormal involuntary movements appear or get worse during therapy.
Caution patient to change positions slowly to minimize orthostatic hypotension. Health care professional should be notified if orthostatic hypotension occurs.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient and family to notify health care professional if signs and symptoms of hallucinations or psychosis (being overly suspicious or feeling people want to harm you, disorientation, believing things that are not real, aggressive behavior, seeing or hearing things that are not real, agitation, confusion, delirium, increase activity or talking), or if new or increased gambling, sexual, or other intense urges occur. Dose reduction may be required.
Advise females of reproductive potential to use effective contraception and avoid breast feeding during therapy. Advise patient to notify health care professional if pregnancy is planned or suspected, or if breast feeding.

NDC Code

0259- Merz Pharmaceuticals, LLC
- 0259-6142- Inbrija
  - 0259-6142-16- 4 BLISTER PACK in 1 CARTON (0259-6142-16) / 4 CAPSULE in 1 BLISTER PACK (0259-6142-01)

0259- Merz Pharmaceuticals, LLC
- 0259-6142- Inbrija
  - 0259-6142-32- 8 BLISTER PACK in 1 CARTON (0259-6142-32) / 4 CAPSULE in 1 BLISTER PACK (0259-6142-01)

0259- Merz Pharmaceuticals, LLC
- 0259-6142- Inbrija
  - 0259-6142-60- 15 BLISTER PACK in 1 CARTON (0259-6142-60) / 4 CAPSULE in 1 BLISTER PACK (0259-6142-01)

10144- Merz Pharmaceuticals, LLC
- 10144-342- Inbrija
  - 10144-342-04- 1 BLISTER PACK in 1 CARTON (10144-342-04) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01)

10144- Merz Pharmaceuticals, LLC
- 10144-342- Inbrija
  - 10144-342-12- 3 BLISTER PACK in 1 CARTON (10144-342-12) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01)

10144- Merz Pharmaceuticals, LLC
- 10144-342- Inbrija
  - 10144-342-16- 4 BLISTER PACK in 1 CARTON (10144-342-16) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01)

10144- Merz Pharmaceuticals, LLC
- 10144-342- Inbrija
  - 10144-342-32- 8 BLISTER PACK in 1 CARTON (10144-342-32) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01)

10144- Merz Pharmaceuticals, LLC
- 10144-342- Inbrija
  - 10144-342-60- 15 BLISTER PACK in 1 CARTON (10144-342-60) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01)

10144- Merz Pharmaceuticals, LLC
- 10144-342- Inbrija
  - 10144-342-92- 23 BLISTER PACK in 1 CARTON (10144-342-92) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01)

11014- Catalent Pharma Solutions, LLC
- 11014-0443-
  - 11014-0443-1- 87500 BLISTER PACK in 1 CONTAINER (11014-0443-1) / 4 CAPSULE in 1 BLISTER PACK

11014- Catalent Pharma Solutions, LLC
- 11014-0733-
  - 11014-0733-1- 87500 BLISTER PACK in 1 CONTAINER (11014-0733-1) / 4 CAPSULE in 1 BLISTER PACK

17333- Ajinomoto Co., Inc.
- 17333-059-
  - 17333-059-01- 50 kg in 1 DRUM (17333-059-01)

49452- Spectrum Laboratory Products, Inc.
- 49452-2680-
  49452-2680-1- 5 g in 1 BOTTLE (49452-2680-1)

49452- Spectrum Laboratory Products, Inc.
- 49452-2680-
  49452-2680-2- 25 g in 1 BOTTLE (49452-2680-2)

49452- Spectrum Laboratory Products, Inc.
- 49452-2680-
  49452-2680-3- 100 g in 1 BOTTLE (49452-2680-3)

49452- Spectrum Laboratory Products, Inc.
- 49452-2680-
  49452-2680-5- 500 g in 1 BOTTLE (49452-2680-5)

49452- Spectrum Laboratory Products, Inc.
- 49452-2680-
  49452-2680-6- 10000 g in 1 DRUM (49452-2680-6)

49452- Spectrum Laboratory Products, Inc.
- 49452-2680-
  49452-2680-7- 25000 g in 1 DRUM (49452-2680-7)

51846- Teva Pharmaceutical Works Private Limited Company
- 51846-1052-
  51846-1052-0- 1 kg in 1 CARTON (51846-1052-0)

51846- Teva Pharmaceutical Works Private Limited Company
- 51846-1053-
  51846-1053-0- 1 kg in 1 CARTON (51846-1053-0)

51927- Professional Compounding Centers of America dba PCCA
- 51927-0049-
  51927-0049-0- 1 kg in 1 CONTAINER (51927-0049-0)

58624- Shandong Xinhua Pharmaceutical Company Limited
- 58624-0234-
  58624-0234-0- 25 kg in 1 DRUM (58624-0234-0)

58624- Shandong Xinhua Pharmaceutical Company Limited
- 58624-0238-
  58624-0238-0- 50 kg in 1 DRUM (58624-0238-0)

62331- Divi's Laboratories Limited
- 62331-013-
  62331-013-31- 50 kg in 1 DRUM (62331-013-31)

64220- ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
- 64220-199-
  64220-199-00- 3 kg in 1 CANISTER (64220-199-00)

64220- ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
- 64220-199-
  64220-199-01- 5 kg in 1 CANISTER (64220-199-01)

64220- ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
- 64220-199-
  64220-199-02- 10 kg in 1 CANISTER (64220-199-02)

64220- ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
- 64220-199-
  64220-199-03- 15 kg in 1 CANISTER (64220-199-03)

64220- ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
- 64220-199-
  64220-199-04- 50 kg in 1 CANISTER (64220-199-04)

64220- ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
- 64220-199-
  64220-199-05- 10 kg in 1 DRUM (64220-199-05)

64220- ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
- 64220-199-
  64220-199-06- 15 kg in 1 DRUM (64220-199-06)

64220- ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
- 64220-199-
  64220-199-07- 20 kg in 1 DRUM (64220-199-07)

64220- ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
- 64220-199-
  64220-199-08- 25 kg in 1 DRUM (64220-199-08)

64220- ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
- 64220-199-
  64220-199-09- 50 kg in 1 DRUM (64220-199-09)

65977- Hetero Drugs Limited
- 65977-0126-
  65977-0126-1- 25 kg in 1 DRUM (65977-0126-1)

70600- Maithri Drugs Private Limited
- 70600-019-
  70600-019-01- 50 kg in 1 DRUM (70600-019-01)

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