Copper
Generic Name: copper
Brand Names:
Miudella
11 DESCRIPTION 11.1 Miudella Miudella (copper intrauterine system) contains 99.99% pure copper for use as a contraceptive. Copper (Cu) has a molecular weight of 63.546 g/mol. Miudella consists of ten copper sleeves attached to a flexible nitinol (nickel-titanium alloy) frame measuring 32 mm horizontally and 30 mm vertically, and a polypropylene monofilament retrieval thread tied to the vertical stem.
Overview
11 DESCRIPTION 11.1 Miudella Miudella (copper intrauterine system) contains 99.99% pure copper for use as a contraceptive. Copper (Cu) has a molecular weight of 63.546 g/mol. Miudella consists of ten copper sleeves attached to a flexible nitinol (nickel-titanium alloy) frame measuring 32 mm horizontally and 30 mm vertically, and a polypropylene monofilament retrieval thread tied to the vertical stem.
Uses
1 INDICATIONS AND USAGE Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. Miudella is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Insert a single Miudella at the fundus of the uterine cavity. Miudella must be removed or replaced after 3 years. ( 2.1 ) Insert Miudella only if you are a trained healthcare provider using clean technique. Follow insertion instructions exactly as described. ( 2.1 ) See the Full Prescribing Information for recommended timing of insertion, preparation instructions, insertion procedures, postplacement management, and instructions on removing Miudella. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) Patient can be re-examined as clinically indicated. 2.1 Important Dosage and Administration Instructions Miudella is supplied sterile in a sealed package with a sterile single use inserter for placement. Do not open the package until required for insertion.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Ectopic pregnancy [see Warnings and Precautions (5.3) ] Intrauterine pregnancy [see Warnings and Precautions (5.4) ] Sepsis [see Warnings and Precautions (5.5) ] Pelvic Infection [see Warnings and Precautions (5.6) ] Perforation [see Warnings and Precautions (5.7) ] Expulsion [see Warnings and Precautions (5.8) ] Wilson's Diseas e [see Warnings and Precautions (5.9) ] Bleeding Pattern Alteration [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥ 5%) are: heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post procedural hemorrhage, dyspareunia.
Warnings
WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [see Warnings and Precautions (5.1) ]. 5 WARNINGS AND PRECAUTIONS Risk of Ectopic Pregnancy : Promptly evaluate females who become pregnant for ectopic pregnancy while using Miudella. ( 5.3 ) Risks with Intrauterine Pregnancy : Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock, and death if pregnancy occurs. Remove Miudella if pregnancy occurs with Miudella in place. ( 5.4 ) Sepsis : Group A streptococcal infection has been reported; strict aseptic technique is essential during insertion. ( 5.5 ) Pelvic Inflammatory Disease (PID) : Promptly evaluate patients with complaints of fever or abdominal pain after insertion of Miudella. ( 5.6 ) Perforation resulting in embedment or translocation : May reduce contraceptive effectiveness and require surgery. 4 CONTRAINDICATIONS The use of Miudella is contraindicated when one or more of the following conditions exist: Pregnancy or suspicion of pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1) ] Congenital or acquired abnormalities of the uterus, including leiomyomas, resulting in distortion of the uterine cavity Acute pelvic inflammatory disease (PID) [see Warnings and...
Pregnancy
8.1 Pregnancy Risk Summary Use of Miudella is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Miudella may cause adverse pregnancy outcomes. If a female becomes pregnant with Miudella in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery [see Contraindications (4) and Warnings and Precautions (5.3 , 5.4) ] . Advise the female of the potential risks if pregnancy occurs with Miudella in place.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Copper used for?▼
1 INDICATIONS AND USAGE Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. Miudella is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.( 1 )
What are the side effects of Copper?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Ectopic pregnancy [see Warnings and Precautions (5.3) ] Intrauterine pregnancy [see Warnings and Precautions (5.4) ] Sepsis [see Warnings and Precautions (5.5) ] Pelvic Infection [see Warnings and Precautions (5.6) ] Perforation [see Warnings and Precautions (5.7) ] Expulsion [see Warnings and Precautions (5.8) ] Wilson's Diseas e [see Warnings and Precautions (5.9) ] Bleeding Pattern Alteration [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥ 5%) are: heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post procedural hemorrhage, dyspareunia.
Can I take Copper during pregnancy?▼
8.1 Pregnancy Risk Summary Use of Miudella is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Miudella may cause adverse pregnancy outcomes. If a female becomes pregnant with Miudella in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery [see Contraindications (4) and Warnings and Precautions (5.3 , 5.4) ] . Advise the female of the potential risks if pregnancy occurs with Miudella in place.
What are the important warnings for Copper?▼
WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [see Warnings and Precautions (5.1) ]. 5 WARNINGS AND PRECAUTIONS Risk of Ectopic Pregnancy : Promptly evaluate females who become pregnant for ectopic pregnancy while using Miudella. ( 5.3 ) Risks with Intrauterine Pregnancy : Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock, and death if pregnancy occurs. Remove Miudella if pregnancy occurs with Miudella in place. ( 5.4 ) Sepsis : Group A streptococcal infection has been reported; strict aseptic technique is essential during insertion. ( 5.5 ) Pelvic Inflammatory Disease (PID) : Promptly evaluate patients with complaints of fever or abdominal pain after insertion of Miudella. ( 5.6 ) Perforation resulting in embedment or translocation : May reduce contraceptive effectiveness and require surgery. 4 CONTRAINDICATIONS The use of Miudella is contraindicated when one or more of the following conditions exist: Pregnancy or suspicion of pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1) ] Congenital or acquired abnormalities of the uterus, including leiomyomas, resulting in distortion of the uterine cavity Acute pelvic inflammatory disease (PID) [see Warnings and...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.