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Rx Item-MOXIDECTIN tablet 2MG TAB BY Medicines Development LTD,

RX71705-050-01 Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-MOXIDECTIN tablet 2MG TAB BY Medicines Development LTD,

$0.00

NDC No. 71705-0050-01 71705-050-01 71705005001 7170505001 UPC/GTIN No. 3-71705-05001-1 371705-050011 371705050011 MPN No. 005001 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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for: Onchocerciasis

Moxidectin is a macrocyclic lactone anthelmintic medicine indicated for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older. 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. hese highlights do not include all the information needed to use
MOXIDECTIN safely and effectively.
See full prescribing information for MOXIDECTIN.
MOXIDECTIN tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE

MOXIDECTIN tablets, for oral use
Initial U.S. Approval: 2018 (1)

(1)

(1)

Moxidectin is an anthelmintic indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older. (1) (1)


Limitations of Use: (1)

Moxidectin Tablets do not kill adult O. volvulus parasites.
Follow-up is advised.
The safety and efficacy of repeat administration of Moxidectin Tablets in patients with O. volvulus has not been studied.These highlights do not include all the information needed to use Moxidectin Tablets. See full prescribing information for Moxidectin Tablets Initial U.S. Approval.

DOSAGE AND ADMINISTRATION

Patients aged 12 years and older: Take 8 mg (four 2 mg tablets) as a
single oral dose, with or without food. (2.1) (2)
DOSAGE FORMS AND STRENGTHS

Tablets: 2 mg. (3) (3)
CONTRAINDICATIONS

None. (4) (4)
WARNINGS AND PRECAUTIONS

• Cutaneous, Ophthalmological and/or Systemic Adverse Reactions of Varying Severity (Mazzotti Reaction): This may occur in patients with onchocerciasis following treatment with Moxidectin Tablets. Monitor patients for symptoms, including symptomatic orthostatic hypotension. (5.1) (5)

(5)

• Symptomatic Orthostatic Hypotension: Episodes of symptomatic orthostatic hypotension including inability to stand without support may occur in patients following treatment with Moxidectin Tablets. (5.2) (5)

(5)

• Encephalopathy in Loa loa co-infected patients: Serious or even fatal encephalopathy following treatment with Moxidectin Tablets may occur in patients co-infected with Loa loa. Assess patients for loiasis in Loa loa endemic areas prior to treatment. (5.3) (5)

(5)

• Edema and Worsening of Onchodermatitis: Patients with hyper-reactive onchodermatitis (sowda) may be more likely than others to experience severe edema and aggravation of onchodermatitis. (5.4) (5)
ADVERSE REACTIONS

The most common adverse reactions (incidence > 10%) were:
eosinophilia, pruritus, musculoskeletal pain, headache, lymphopenia,
tachycardia, rash, abdominal pain, hypotension, pyrexia, leukocytosis,
influenza-like illness, neutropenia, cough, lymph node pain, dizziness,
diarrhea, hyponatremia and peripheral swelling. (6) (6)

(6)

To report SUSPECTED ADVERSE REACTIONS, contact
Medicines Development for Global Health at 1-800-MDGH-456 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)

Revised: 6/2018

RX71705-050-01
Rx Item-MOXIDECTIN tablet 2MG TAB BY Med
RX71705-050-01

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-MOXIDECTIN tablet 2MG TAB BY Med
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop