ATELVIA- risedronate sodium tablet, delayed release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

RISEDRONATE SODIUM HEMI-PENTAHYDRATE (UNII: HU2YAQ274O) (RISEDRONIC ACID - UNII:KM2Z91756Z), RISEDRONATE SODIUM MONOHYDRATE (UNII: F67L43UT5C) (RISEDRONIC ACID - UNII:KM2Z91756Z)

Διαθέσιμο από:

Allergan, Inc.

INN (Διεθνής Όνομα):

RISEDRONATE SODIUM HEMI-PENTAHYDRATE

Σύνθεση:

RISEDRONATE SODIUM ANHYDROUS 30.1 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Atelvia is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1) ]. The optimal duration of use has not been determined. The safety and effectiveness of Atelvia for the treatment of osteoporosis are based on clinical data of one year duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically. Atelvia is contraindicated in patients with the following conditions: • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.2) ]  • Inability to stand or sit upri

Περίληψη προϊόντος:

Atelvia® (risedronate sodium) delayed-release tablets are: 35 mg, yellow, oval-shaped, and engraved with EC 35 on one side. NDC 0430-0979-03       Dosepak of 4 tablets Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

Καθεστώς αδειοδότησης:

New Drug Application

Φύλλο οδηγιών χρήσης

Allergan, Inc.
----------
Medication Guide
Atelvia® (uh-TEL-v-uh)
(risedronate sodium)
delayed-release tablets
Read this Medication Guide that comes with Atelvia® before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking with your
doctor about your medical condition or your treatment. Talk to your
doctor if you have any questions
about Atelvia, there may be new information about it.
What is the most important information I should know about Atelvia?
Atelvia can cause serious side effects including:
1.
Esophagus problems
2.
Low calcium levels in your blood (hypocalcemia)
3.
Severe jaw bone problems (osteonecrosis)
4.
Bone, joint, or muscle pain
5.
Unusual thigh bone fractures
1. Esophagus problems.
Some people who take Atelvia may develop problems in the esophagus
(the tube that connects the mouth
and the stomach). These problems include irritation, inflammation, or
ulcers of the esophagus which may
sometimes bleed.
•
It is important that you take Atelvia exactly as prescribed to help
lower your chance of getting
esophagus problems. (See the section “How should I take Atelvia?”)
•
Stop taking Atelvia and call your doctor right away if you get chest
pain, new or worsening
heartburn, or have trouble or pain when you swallow.
2. Low calcium levels in your blood (hypocalcemia).
Atelvia may lower the calcium levels in your blood. If you have low
blood calcium before you start
taking Atelvia, it may get worse during treatment. Your low blood
calcium must be treated before you
take Atelvia. Most people with low blood calcium levels do not have
symptoms, but some people may
have symptoms. Call your doctor right away if you have symptoms of low
blood calcium such as:
•
Spasms, twitches, or cramps in your muscles
•
Numbness or tingling in your fingers, toes, or around your mouth
Your doctor may prescribe calcium and vitamin D to help prevent low
calcium levels in your blood, while
you are taking Atelvia. Take calcium and vi

Αρχείο Π.Χ.Π.

ATELVIA- RISEDRONATE SODIUM TABLET, DELAYED RELEASE
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATELVIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATELVIA.
ATELVIA (RISEDRONATE SODIUM) DELAYED-RELEASE TABLETS
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Atelvia is a bisphosphonate in a delayed-release formulation and is
indicated for treatment of
postmenopausal osteoporosis (1.1)
Limitations of Use
Optimal duration of use has not been determined. For patients at
low-risk for fracture, consider drug
discontinuation after 3 to 5 years of use (1.2)
DOSAGE AND ADMINISTRATION
One 35 mg delayed-release tablet once-a-week (2.1)
Instruct patients to:
Take Atelvia in the morning immediately _following breakfast_ with at
least 4 ounces of plain water (2.2)
Avoid lying down for 30 minutes after taking Atelvia (2.2)
Take supplemental calcium and vitamin D if dietary intake is
inadequate (2.3)
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets: 35 mg (3)
CONTRAINDICATIONS
Abnormalities of the esophagus which delay esophageal emptying such as
stricture or achalasia (4,
5.2)
Inability to stand or sit upright for at least 30 minutes (4, 5.2)
Hypocalcemia (4, 5.3)
Known hypersensitivity to any component of this product (4, 6.2)
WARNINGS AND PRECAUTIONS
_Products Containing Same Active Ingredient_: Patients receiving
Actonel should not be treated
with Atelvia (5.1)
_Upper Gastrointestinal Adverse Reactions_ can occur. Instruct
patients to follow dosing instructions.
Discontinue use if new or worsening symptoms occur (5.2)
_Hypocalcemia_ may worsen and must be corrected prior to use (5.3)
_Osteonecrosis of the Jaw_ has been reported (5.4)
_Severe Bone, Joint, Muscle Pain_ may occur. Discontinue use if severe
symptoms develop (5.5, 6.2)
_Atypical Femur Fractures_ have been reported. Patients with new thigh
or groin pain should be evaluated
to rule out a femoral fracture (5.6)
ADVERSE REACTIONS
Most common adverse reactions (g