Moxidectin (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Moxidectin Tablets containing 2 mg moxidectin are white to pale yellow uncoated oval-shaped tablets, debossed on one side with “AKKA”. Each high-density polyethylene bottle contains 500 tablets (NDC 71705-050-01), a silica gel desiccant and polyester coil.

Store below 30°C (86°F).

  • Protect from light.
  • Once open, the full contents of the container should be used within 24 hours with any unused content discarded.

17 PATIENT COUNSELING INFORMATION

Signs and Symptoms Associated with Microfilarial Death

Advise patients that they are likely to have flu like symptoms including malaise, myalgia, headache, tachycardia, hypotension and pruritus, most commonly during the first week after treatment.

Symptomatic Orthostatic Hypotension

Advise patients that if they feel dizzy, faint or light-headed after taking Moxidectin Tablets, they should lie down until the symptoms resolve.

Absence of Macrofilarial Activity

Advise patients that treatment with Moxidectin Tablets does not kill adult O . volvulus and that follow up evaluation is usually required.

Edema and Worsening of Onchodermatitis

Advise patients with hyper-reactive onchodermatitis that they may be more likely to experience severe adverse reactions.

Encephalopathy in Loa loa Co-infected Patients

Advise patients to report any symptoms of encephalopathy to their healthcare provider.

Lactation

Advise women that breastfeeding is not recommended at the time of treatment with Moxidectin Tablets and for 7 days after treatment.

Manufactured for: Medicines Development for Global Health, Melbourne, Victoria, Australia

© 2021 Medicines Development for Global Health. All rights reserved.

PRINCIPAL DISPLAY PANEL

NDC 71705-050-01
moxidectin
tablets
2 mg
500 tablets Rx Only

NDC 71705-050-01
moxidectin
tablets
2 mg
500 tablets
Rx Only
(click image for full-size original)
MOXIDECTIN moxidectin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71705-050
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIDECTIN (MOXIDECTIN) MOXIDECTIN 2 mg
Product Characteristics
Color white (White to pale yellow) Score no score
Shape OVAL Size 8mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71705-050-01 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210867 12/02/2019
Labeler — Medicines Development for Global Health (754191398)

Revised: 11/2023 Medicines Development for Global Health

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