Fem Repair Non-preg

For the prevention of pregnancy, the standard dosage of Antimony Arsenate is the insertion of a single intrauterine system containing approximately 380 mm² of active surface area. This single dose provides continuous contraceptive protection for a period of up to 10 years. No supplementary doses or daily medications are required once the device is successfully placed by a healthcare professional.

Antimony Arsenate is approved for use in females of reproductive age, including post-menarcheal adolescents (those who have started their menstrual periods). There is no specific age-based dosage adjustment required for adolescents; the same device used for adults is utilized. However, the size of the uterus must be carefully measured (sounded) by a clinician to ensure the device can be safely accommodated. It is not indicated for use before the onset of menses.

Renal Impairment

Because the action of Antimony Arsenate is localized to the uterus and systemic absorption is negligible, no dosage adjustments are typically required for patients with mild to moderate renal impairment. However, patients with severe renal disease should be monitored for any signs of systemic accumulation, although this is theoretically unlikely.

Hepatic Impairment

There are no known requirements for dosage adjustment in patients with hepatic impairment, as the compound does not undergo significant hepatic metabolism.

Elderly Patients

Antimony Arsenate is not indicated for use in post-menopausal women, as contraception is no longer necessary. It should be removed once menopause is confirmed (typically after 12 consecutive months of amenorrhea).

Antimony Arsenate is not 'taken' in the traditional sense; it is inserted into the uterus by a trained healthcare provider during an in-office procedure.

• Timing: Insertion is often recommended during the menstrual period to ensure the patient is not pregnant and because the cervix is naturally slightly more open.
• Procedure: The provider will perform a pelvic exam, clean the cervix with an antiseptic, and use a thin inserter tube to place the device through the cervical canal into the uterus. The procedure usually takes less than 10 minutes.
• Post-Insertion: Patients may experience cramping or spotting immediately following the procedure. It is recommended to rest for a short period before leaving the clinic.
• Storage: Before use, the sterile package should be stored at controlled room temperature (15°C to 30°C or 59°F to 86°F).

Since the device provides continuous protection for 10 years, there is no risk of a 'missed dose' in the way one might miss a pill. However, if the device is expelled (falls out), the patient is no longer protected against pregnancy and must contact their healthcare provider immediately. Backup contraception (such as condoms) should be used until a new device is inserted.

Systemic overdose of Antimony Arsenate from an intrauterine device is virtually impossible due to the slow-release nature of the compound. However, 'overdose' in this context may refer to the rare occurrence of accidental insertion of a second device without removing the first. This can lead to severe uterine trauma, pain, and bleeding. If you suspect an issue with the device, seek medical evaluation immediately. Signs of systemic toxicity from the components (antimony or arsenic) would include severe gastrointestinal distress, metallic taste, and neurological symptoms, though these have not been reported with standard IUD use.

> Important: Follow your healthcare provider's dosing instructions. Do not attempt to remove or adjust the device yourself, as this can cause injury or infection.

Most patients using Antimony Arsenate will experience some changes in their menstrual patterns. These are typically most pronounced during the first 3 to 6 months following insertion.

• Heavier Menstrual Periods (Menorrhagia): Many users report an increase in the volume of menstrual blood flow. This can sometimes lead to iron-deficiency anemia if the blood loss is significant.
• Increased Menstrual Cramping (Dysmenorrhea): Painful periods are common, especially in the months immediately following placement. This is often manageable with over-the-counter pain relievers like ibuprofen.
• Spotting Between Periods: Random bleeding or spotting between regular cycles is frequently observed during the initial adjustment period.

• Vaginal Discharge: An increase in non-infectious vaginal discharge may occur as the uterus adjusts to the presence of the device.
• Dyspareunia (Painful Intercourse): Some patients or their partners may feel the strings of the device, or the patient may experience deep pelvic pain during intercourse.
• Backache: Persistent low back pain may be associated with the uterine response to the device.

• Device Expulsion: The uterus may occasionally contract and push the device out, either partially or completely. This is more common in the first year of use and in women who have never given birth.
• Pelvic Inflammatory Disease (PID): While the device itself does not cause infection, the insertion process can introduce bacteria into the uterus, leading to PID, particularly within the first 20 days after insertion.
• Uterine Perforation: In rare cases, the device may be pushed through the wall of the uterus during insertion. This requires surgical removal.

> Warning: Stop taking Antimony Arsenate (seek device removal) and call your doctor immediately if you experience any of these serious symptoms.

• Severe Pelvic Pain or Tenderness: This could indicate an infection, ectopic pregnancy, or uterine perforation.
• Unexplained Fever and Chills: These are signs of a potential systemic infection or PID.
• Foul-smelling Vaginal Discharge: A strong, unpleasant odor may indicate a bacterial infection that requires antibiotic treatment.
• Missing Strings: If you can no longer feel the retrieval strings at the cervix, the device may have moved or been expelled.
• Pregnancy Symptoms: If you suspect you are pregnant while the device is in place, you must seek medical care immediately due to the high risk of ectopic pregnancy.

Prolonged use of Antimony Arsenate (up to the 10-year limit) is generally well-tolerated. The most significant long-term concern is the potential for chronic heavy bleeding leading to anemia. Patients should have their hemoglobin levels monitored periodically if they report consistently heavy cycles. There is no evidence that long-term use of this device affects future fertility; once the device is removed, the contraceptive effect is reversed immediately.

There are currently no FDA black box warnings specifically for Antimony Arsenate. However, general warnings for all intrauterine devices include the risk of Pelvic Inflammatory Disease (PID) and the risk of ectopic pregnancy if conception occurs with the device in place.

Report any unusual symptoms to your healthcare provider. Early detection of complications like PID or perforation is essential for preventing long-term reproductive health issues.

Antimony Arsenate is a highly effective contraceptive, but it is not suitable for everyone. Patients must undergo a comprehensive screening for pelvic infections and uterine abnormalities before insertion. It is critical to understand that this device does not offer any protection against sexually transmitted infections (STIs), including HIV/AIDS. Patients in non-monogamous relationships should continue to use barrier methods (condoms) for STI protection.

No FDA black box warnings for Antimony Arsenate. However, clinical guidelines emphasize that the device must be removed immediately if pregnancy is detected, as there is a significantly increased risk of septic abortion, preterm labor, and maternal death if the device remains in a pregnant uterus.

• Ectopic Pregnancy Risk: While the overall risk of pregnancy is very low, if a patient does become pregnant while using Antimony Arsenate, the likelihood that the pregnancy is ectopic (located outside the uterus) is greatly increased. Ectopic pregnancy is a medical emergency that can lead to internal bleeding and loss of fertility.
• Sepsis: Cases of group A streptococcal sepsis have been reported following the insertion of intrauterine devices. Severe pain or fever shortly after insertion requires immediate evaluation.
• Actinomycosis: Long-term use of IUDs has been associated with the growth of Actinomyces bacteria in the genital tract. While often asymptomatic, it can lead to serious pelvic abscesses.
• MRI Safety: Most Antimony Arsenate devices are considered 'MR Conditional.' Patients must inform their radiologist that they have an IUD before undergoing an MRI scan, as the metal components can cause artifacts or slight heating.

Patients should be scheduled for a follow-up visit approximately 4 to 6 weeks after insertion to ensure the device is still properly positioned. After the initial check, an annual pelvic exam is recommended. Patients are also instructed to perform a self-check for the device strings once a month, usually after their menstrual period, to confirm the device has not been expelled.

Antimony Arsenate has no known effect on the ability to drive or operate heavy machinery. Some patients may feel faint or dizzy immediately following the insertion procedure (vasovagal reaction), so it is advised to wait until these symptoms pass before driving home from the clinic.

There are no known direct interactions between alcohol consumption and the efficacy or safety of Antimony Arsenate. However, heavy alcohol use may impair a patient's ability to monitor for side effects or attend follow-up appointments.

Antimony Arsenate can be removed at any time by a healthcare provider if the patient decides they want to become pregnant or switch to another method of contraception. Removal is usually a quick and simple procedure. Fertility returns to the patient's baseline immediately upon removal. If the device has reached its 10-year expiration, it must be removed and can be replaced with a new one during the same visit if continued contraception is desired.

> Important: Discuss all your medical conditions with your healthcare provider before starting Antimony Arsenate, especially if you have a history of pelvic infections or heart valve disease.

There are no specific drugs that are absolutely contraindicated for use with Antimony Arsenate due to its localized action. However, the device should not be inserted in patients currently undergoing systemic chemotherapy or those with severe immunosuppression, as the risk of pelvic infection is significantly elevated in these populations.

• Anticoagulants and Antiplatelets: Drugs such as warfarin (Coumadin), clopidogrel (Plavix), or apixaban (Eliquis) may exacerbate the heavy menstrual bleeding (menorrhagia) commonly caused by Antimony Arsenate. Patients on chronic anticoagulation therapy should be monitored for signs of anemia and may require alternative contraceptive methods if bleeding becomes unmanageable.
• Corticosteroids: Long-term use of systemic steroids (e.g., prednisone) can suppress the immune system and potentially increase the risk of Pelvic Inflammatory Disease (PID) in IUD users.

• Nonsteroidal Anti-inflammatory Drugs (NSAIDs): While NSAIDs like naproxen or ibuprofen are often used to treat the cramping associated with Antimony Arsenate, some theoretical concerns have been raised about whether frequent use of high-dose NSAIDs could interfere with the local inflammatory response required for the device's contraceptive efficacy. However, most clinical data suggest that NSAIDs do not reduce the effectiveness of copper-containing IUDs.

There are no known food or beverage interactions with Antimony Arsenate. Because the drug is not absorbed through the digestive tract, dietary choices, including grapefruit juice or dairy products, do not affect its performance.

• Iron Supplements: While not an 'interaction' that reduces efficacy, many patients using Antimony Arsenate may require iron supplementation to counteract the blood loss from heavier periods.
• St. John's Wort: Unlike hormonal contraceptives, the efficacy of Antimony Arsenate is not affected by St. John's Wort or other herbal supplements that induce liver enzymes (CYP3A4).

Antimony Arsenate does not typically interfere with standard blood or urine laboratory tests. However, the presence of the device may be visible on various imaging studies:

• Abdominal X-ray: The device is radiopaque and will be clearly visible.
• Ultrasound: The device produces a characteristic 'shadowing' effect on pelvic ultrasounds, which is used to confirm its correct placement.
• Pap Smear: Cytological changes or the presence of Actinomyces-like organisms may be noted on a Pap smear, which should be clinically correlated by a physician.

For each major interaction, the primary concern is the management of side effects rather than a loss of contraceptive efficacy. Because the device works through a physical and local chemical presence, systemic drug-drug interactions are exceptionally rare.

> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, especially those that affect blood clotting or immune function.

Antimony Arsenate must NEVER be used in the following circumstances:

• Pregnancy: The device is strictly contraindicated if pregnancy is known or suspected, as it can cause severe maternal and fetal complications.
• Distorted Uterine Cavity: Any anatomical abnormality (e.g., large fibroids, bicornuate uterus) that prevents the proper placement of the device is an absolute contraindication.
• Acute Pelvic Inflammatory Disease (PID): Patients with current PID or a history of PID within the last three months should not have the device inserted.
• Unexplained Vaginal Bleeding: Before insertion, the cause of any abnormal bleeding must be diagnosed to rule out malignancy or other serious conditions.
• Current Malignancy: Known or suspected cancer of the uterus or cervix.
• Wilson's Disease: Although the device contains Antimony Arsenate, it is often grouped with copper IUDs; patients with Wilson's disease (a rare genetic disorder of copper metabolism) should avoid metallic IUDs.

Conditions requiring careful risk-benefit analysis include:

• History of Ectopic Pregnancy: While the IUD prevents most pregnancies, a history of ectopic pregnancy increases the risk if the IUD fails.
• Multiple Sexual Partners: Patients at high risk for STIs have a higher risk of developing PID following IUD insertion.
• Anemia: Patients with pre-existing severe anemia may not tolerate the increased menstrual blood loss associated with the device.

Patients with a known allergy to antimony, arsenic, copper, or polyethylene should not use this device. An allergic reaction could manifest as localized uterine inflammation or, in rare cases, systemic dermatitis. If a patient has a known 'nickel allergy,' they should be monitored closely, although Antimony Arsenate devices typically do not contain nickel.

> Important: Your healthcare provider will evaluate your complete medical history, including a pelvic exam and possibly an ultrasound, before prescribing Antimony Arsenate.

Antimony Arsenate is categorized as FDA Pregnancy Category X (or equivalent). It is intended to prevent pregnancy and has no place in the treatment of pregnant women. If pregnancy occurs with the device in place, there is a high risk of ectopic pregnancy, septic abortion (a life-threatening infection of the uterus), and premature labor. The device should be removed as soon as the pregnancy is discovered, regardless of whether the patient intends to continue the pregnancy.

Antimony Arsenate is considered safe for use during breastfeeding. The metallic ions released by the device act locally within the uterus, and there is no evidence that clinically significant amounts of antimony or arsenic pass into breast milk. According to the World Health Organization (WHO), IUDs can be inserted immediately postpartum (within 48 hours) or after 4 weeks, even in breastfeeding women.

Antimony Arsenate is safe and effective for use in adolescents who have reached menarche. Clinical studies have shown that LARCs like Antimony Arsenate are highly effective at preventing unintended teenage pregnancies. Special care must be taken during insertion in nulliparous (those who have never given birth) adolescents, as the cervical canal may be narrower and the risk of expulsion slightly higher.

This device is not indicated for use in the geriatric population. It is designed for women of reproductive age. In women approaching menopause, the device should be removed once they have been amenorrheic for one year, as the risks of the device (such as infection or difficult removal) outweigh any remaining contraceptive benefit.

As the device operates through local ion release with minimal systemic absorption, no dosage adjustments are necessary for patients with renal impairment. However, clinicians should exercise caution in patients with end-stage renal disease (ESRD) due to potential changes in inflammatory responses.

No adjustments are required for patients with hepatic impairment. The device does not rely on liver function for its contraceptive efficacy or for the clearance of its active components.

> Important: Special populations require individualized medical assessment. Always inform your provider about your reproductive goals and any nursing status.

Antimony Arsenate functions as a non-hormonal contraceptive through several interrelated pathways. The primary mechanism is the creation of a cytotoxic uterine environment. The device continuously releases ions that are toxic to sperm cells (spermicidal). These ions inhibit essential sperm enzymes, particularly those involved in carbohydrate metabolism and motility. Additionally, the presence of the device triggers a 'foreign body reaction,' leading to an increase in intrauterine leukocytes, prostaglandins, and enzymes that prevent the sperm from successfully fertilizing the ovum. If fertilization does occur, the inflammatory changes in the endometrium prevent the blastocyst from implanting.

The pharmacodynamic effect of Antimony Arsenate is strictly local. The 'dose-response' is determined by the surface area of the metal exposed to the uterine fluid. A surface area of 380 mm² is the clinical standard for 10-year efficacy. The onset of action is immediate upon insertion. The duration of effect is maintained as long as the device remains in the uterine cavity, up to its expiration date. There is no evidence of the development of 'tolerance' to the contraceptive effects over time.

| Parameter | Value |

|---|---|

| Bioavailability | <0.1% (Systemic) |

| Protein Binding | N/A (Local action) |

| Half-life | N/A (Continuous release) |

| Tmax | N/A (Steady-state local release) |

| Metabolism | None (Inorganic salt) |

| Excretion | Vaginal secretions (Primary) |

• Molecular Formula: $SbAsO_4$
• Molecular Weight: 260.67 g/mol
• Solubility: Very slightly soluble in water; solubility increases in the acidic/enzymatic environment of the uterus.
• Structure: Antimony Arsenate is an inorganic salt. In the IUD, it is often incorporated into a metallurgical blend or applied as a coating to a polyethylene frame.

Antimony Arsenate is classified as a Copper-containing Intrauterine Device [EPC]. This class also includes devices made of elemental copper (e.g., ParaGard). These are distinguished from hormonal intrauterine systems (e.g., Mirena, Kyleena), which release levonorgestrel.